Methods of Locating and Treating Tissue in a Wall Defining a Bodily Passage

ABSTRACT

Devices, kits, and methods of treatment are described. More particularly, methods of treating tissue of a passage wall defining a bodily passage, such as a sinus cavity, airway, or sinus passage are described. An exemplary method utilizes an elongate member having an elongate member proximal end, elongate member distal end, and an elongate member body that defines a curve.

RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.14/449,207, which was filed on Aug. 1, 2014 and which claims the benefitof U.S. Provisional Application No. 61/861,029, filed on Aug. 1, 2013.The disclosure of each of these related applications is herebyincorporated into this disclosure in its entirety.

FIELD

The disclosure relates generally to methods of treatment. Moreparticularly, the disclosure relates to methods of locating and treatingtissue in a wall defining a bodily passage, such as a sinus passage,airway, or sinus cavity. The disclosure also relates to devices and kitsfor treating tissue in a wall defining a bodily passage, such as a sinuspassage, airway, or sinus cavity.

BACKGROUND

To treat stenosis—the narrowing of a bodily passage—physiciansfrequently dilate the bodily passage using a balloon catheter. Forexample, when functioning normally, sinus passages allow mucus to drainfrom the sinus cavities and allow air to circulate throughout therespiratory system. However, when a sinus passage, such as an ostium,becomes blocked and prevents the outflow of material from a sinuscavity, infection can occur resulting in sinusitis.

To treat these conditions, physicians sometimes systematicallyadminister drugs at a treatment site within the sinus or prescribeantibiotics to reduce inflammation and/or treat the infection.Alternatively, balloon sinuplasty—the dilation of a sinus passage usinga balloon catheter—can be performed to unblock the sinus passage.Conventional sinuplasty procedures advance a balloon catheter over apreviously placed guide wire and move the balloon to an inflatedconfiguration to effectuate dilation and unblock the obstructed passage.However, these procedures are complicated by the need to navigate andposition the guide wire prior to positioning the balloon catheter at apoint of treatment (e.g., within an ostium). For example, the guide wiremust be advanced through the nasal passage and then navigated throughthe ostium, which may be disposed at an abrupt angle to the nasalpassage. The structural arrangement of the nasal passage relative to theostium increases the difficulty and time required to advance the guidewire through the ostium such that a balloon catheter can be advanced tothe point of treatment.

Therefore, a need exists for improved devices, methods, and kits forlocating and treating tissue in a wall defining a bodily passage, suchas a sinus passage, airway, or sinus cavity.

SUMMARY

Several exemplary devices, methods, and kits for locating and treatingtissue in a wall defining a bodily passage, such as a sinus passageway,airway, or sinus cavity are described herein.

Additional understanding of the exemplary devices, methods, and kits canbe obtained by review of the detailed description, presented below, andthe referenced drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a flowchart representation of an exemplary method of treatingtissue in a wall defining a bodily passage.

FIG. 2 is a sectional view of an exemplary catheter disposed within acannula. The catheter is in the first straight, or substantiallystraight, configuration.

FIG. 3 is a side view of the exemplary catheter illustrated in FIG. 2,free of the cannula and in the second curved configuration.

FIG. 4 is a flowchart representation of another exemplary method oftreating tissue in a wall defining a bodily passage.

FIG. 5 is a sectional view of an exemplary delivery device.

FIG. 6 is a flowchart representation of another exemplary method oftreating tissue in a wall defining a bodily passage.

FIG. 6A is a partial sectional view of a patient with the deliverydevice illustrated in FIG. 5 partially disposed in a nasal passage. Theelongate member is in the first straight, or substantially straight,configuration.

FIG. 6B is a partial sectional view of a patient with the deliverydevice illustrated in FIG. 5 partially disposed in a nasal passage in apartially deployed configuration. The elongate member is in the secondcurved configuration.

FIG. 6C is a partial sectional view of a patient with the deliverydevice illustrated in FIG. 5 partially disposed in a nasal passage. Theballoon of the catheter is in the inflated configuration.

FIG. 6D is a partial sectional view of a nasal passage followingtreatment.

FIG. 7 is a sectional view of an exemplary insert disposed withinanother exemplary catheter. The catheter is disposed within a cannulaand is in the first straight, or substantially straight, configuration.

FIG. 8 is a side view of the exemplary insert and catheter illustratedin FIG. 7, free of the cannula and in the second curved configuration.

FIG. 9 is a side view of the exemplary insert illustrated in FIGS. 7 and8, free of the catheter and in the second curved configuration.

FIG. 10 illustrates an exemplary kit.

FIG. 11 is a flowchart representation of another exemplary method oftreating tissue in a wall defining a bodily passage.

FIG. 12 is a side view of another exemplary insert. The insert is in thefirst straight, or substantially straight, configuration.

FIG. 13 is a side view of the exemplary insert illustrated in FIG. 12 inthe second curved configuration.

FIG. 14 is a flowchart representation of another exemplary method oftreating tissue in a wall defining a bodily passage.

DETAILED DESCRIPTION

The following detailed description and the appended drawings describeand illustrate various exemplary methods, delivery devices, cannulas,and catheters. The description and drawings are exemplary in nature andare provided to enable one skilled in the art to practice one or moreexemplary methods and/or make one or more exemplary delivery devices,cannulas, and/or catheters. They are not intended to limit the scope ofthe claims in any manner.

The use of “e.g.,” “etc.,” “for instance,” “in example,” and “or” andgrammatically related terms indicate non-exclusive alternatives withoutlimitation, unless otherwise noted. The use of “optionally” andgrammatically related terms means that the subsequently describedelement, event, feature, or circumstance may or may not be present oroccur, and that the description includes instances where said element,event, feature, or circumstance occurs and instances where it does not.The use of “exemplary” refers to “an example of” and is not intended toconvey a meaning of an ideal or preferred embodiment. The use of“attached” refers to the fixed, releasable, or integrated association oftwo or more elements and/or devices. Thus, the term “attached” includesreleasably attaching or fixedly attaching two or more elements and/ordevices. As used herein, the terms “proximal” and “distal” are used todescribe opposing axial ends of the particular element or feature beingdescribed. The term “bodily passage” or “body passage” refers to anypassage within the body of an animal, including, but not limited to,humans, and includes elongate passages. The term “sinus passage” refersto the nasal passages and includes, but is not limited to, eustachiantube(s), primary ostium, accessory ostium, and/or an opening defined bya ventilation tube. The term “airway” refers to any airway including,but not limited to, the nasopharynx, oropharynx, pharynx, trachea,bronchial tubes, and/or lungs. The term “sinus cavity” refers to thefrontal, ethmoid, sphenoid, and/or maxillary sinus.

Various methods of treatment are provided. These methods includetreating tissue in a wall defining a bodily passage, such as a sinuspassage, airway, or sinus cavity. While some methods of treating tissuein a wall defining a bodily passage are exemplified by methods oftreating an opening defined by the wall of a bodily passage or treatingtissue in a wall defining a sinus passage, airway, or sinus cavity, themethods can also be used to treat tissue in a wall defining any othersuitable bodily passage, and skilled artisans will be able to select asuitable tissue for treatment with a particular method based on variousconsiderations, such as the nature of the treatment to be performed.Examples of other tissues considered suitable to treat using one or moreof the methods and/or steps described herein include, but are notlimited to, the tissue in a wall defining the urinary tract, and thetissue in a wall defining any other bodily passage considered suitablefor a particular application.

While the methods described herein are shown and described as a seriesof acts, it is to be understood and appreciated that the methods are notlimited by the order of acts, as some acts may, in accordance with thesemethods, be omitted, occur in different orders with other acts describedherein, and/or concurrently with other acts described herein.

FIG. 1 is a flowchart representation of an exemplary method 100 oftreating tissue in a passage wall defining a bodily passage.

A step 102 comprises inserting a cannula having a cannula proximal end,a cannula distal end, and a cannula body defining a cannula lumen into abodily passage such that the cannula distal end is disposed within thebodily passage. Another step 104 comprises introducing a catheter havingan elongate member and balloon into the cannula lumen. The elongatemember having an elongate member proximal end, elongate member distalend, elongate member length, and an elongate member body that defines aninflation lumen and an elongate member curve. The elongate member lengthextends from the elongate member proximal end to the elongate memberdistal end. The elongate member curve is defined along a portion of theelongate member. The elongate member is adapted to move between a firststraight, or substantially straight, configuration in which the portionof the elongate member that defines the elongate member curve isstraight, or substantially straight, when disposed within the cannulalumen and a second curved configuration in which the portion of elongatemember that defines the elongate member curve is curved when free of, ordisposed outside of, the cannula lumen. The balloon is disposed on theelongate member and has a balloon wall that defines a balloon chamber incommunication with the inflation lumen. The balloon is moveable betweena first deflated configuration and a second inflated configuration asfluid is moved into and out of the balloon chamber. Another step 106comprises navigating the cannula toward a point of treatment within thebodily passage. The point of treatment comprises an opening defined bythe wall of the bodily passage. Another step 108 comprises advancing theelongate member distally through the cannula lumen such that the portionof the elongate member that defines the elongate member curve is freeof, or disposed outside of, the cannula lumen and the elongate membermoves from the first configuration to the second configuration. Thus,the elongate member adopts a curved configuration. Another step 110comprises navigating the elongate member distal end toward the openingdefined by the passage wall. Another step 112 comprises advancing theelongate member distal end through the opening defined by the passagewall such that the balloon is positioned through the opening. Anotherstep 114 comprises passing a fluid through the inflation lumen and intothe balloon chamber to move the balloon toward the second inflatedconfiguration. Another step 116 comprises stopping the step of passing afluid through the inflation lumen and into the balloon chamber. Anotherstep 118 comprises removing a portion of the fluid from the balloonchamber. Another step 120 comprises withdrawing the elongate member fromthe opening defined by the passage wall. Another step 122 compriseswithdrawing the catheter from the cannula lumen. Another step 124comprises withdrawing the cannula from the bodily passage.

Step 102 can be accomplished by applying a distally-directed force(e.g., toward bodily passage) on any suitable portion of a cannula suchthat the cannula distal end is passed into the bodily passage (e.g.,through an opening defined by a passage wall). Any suitable cannulahaving any suitable structural arrangement can be used to accomplishstep 102, and skilled artisans will be able to select a suitable cannulaand structural arrangement for a cannula according to a particularembodiment based on various considerations, including the tissue desiredto be treated. FIG. 2 illustrates an exemplary cannula 200 having acannula proximal end 202, a cannula distal end 204, and a cannula body206. The cannula body 206 defines a cannula first opening 208, a cannulasecond opening 210, and a cannula lumen 212 that extends from thecannula first opening 208 to the cannula second opening 210.

The cannula 200 can be formed of any suitable material and fabricatedusing any suitable technique, and skilled artisans will be able toselect a suitable material to form a cannula and a suitable technique tofabricate a cannula according to a particular embodiment based onvarious considerations, including the desired flexibility of thecannula. Example materials considered suitable to form a cannulainclude, but are not limited to, biocompatible materials, materials thatcan be made biocompatible, metals such as stainless steel, titanium,nitinol, cobalt chromium, polymers, Pebax (Pebax is a registeredtrademark of Ato Chimie Corporation of Allee des Vosges, Courbevoie,France), nylon, polyethylene, polyurethane, silicone, coiled materials,braided materials, and any other material considered suitable for aparticular application.

Step 104 can be accomplished by applying a distally-directed force(e.g., toward bodily passage) on any suitable portion of a catheter suchthat a portion of the catheter (e.g., portion of elongate member), or atleast a portion of the catheter (e.g., at least a portion of elongatemember), is passed into the cannula lumen (e.g., through an openingdefined by the cannula body, cannula first opening 208). Any suitablecatheter having any suitable structural arrangement can be used toaccomplish step 104, and skilled artisans will be able to select asuitable catheter and structural arrangement for a catheter according toa particular embodiment based on various considerations, including theprocedure intended to be performed. FIGS. 2 and 3 illustrate anexemplary balloon catheter 220 comprising an elongate member 222 andballoon 224.

Optionally, a catheter can be preloaded within a cannula such that step104 can be omitted from method 100. Alternatively, step 104 can beaccomplished prior to step 102 such that a catheter is introduced into acannula prior to the cannula being introduced into a bodily passage.

The elongate member 222 can be formed of any suitable material andfabricated using any suitable technique, and skilled artisans will beable to select a suitable material to form an elongate member and asuitable technique to fabricate an elongate member according to aparticular embodiment based on various considerations, including thedesired flexibility of the elongate member. Example materials consideredsuitable to form an elongate member include, but are not limited to,biocompatible materials, materials that can be made biocompatible,metals such as stainless steel, titanium, nitinol, cobalt chromium,polymers, Pebax (Pebax is a registered trademark of Ato ChimieCorporation of Allee des Vosges, Courbevoie, France), nylon,polyethylene, polyurethane, silicone, coiled materials, braidedmaterials, and any other material considered suitable for a particularapplication.

The elongate member 222 can have any suitable outside diameter andlength, and skilled artisans will be able to select a suitable outsidediameter and length for an elongate member according to a particularembodiment based on various considerations, including the desired bodilypassage within which the catheter is intended to be used. It isconsidered advantageous for the elongate member 222 to have an outsidediameter that is less than the inside diameter of the cannula lumen 212.It is also considered advantageous for the elongate member 222 to havean elongate member length that is greater than the length of cannula200.

In the illustrated embodiment, the elongate member 222 comprises anelongate member proximal end 226, an elongate member distal end 228, andan elongate member body 230. The elongate member 222 has an elongatemember length that extends from the elongate member proximal end 226 tothe elongate member distal end 228. The elongate member body 230 definesan elongate member first opening 234, an elongate member second opening236, an inflation lumen 238, and an elongate member curve 240 (e.g.,predefined curve).

In the illustrated embodiment, the elongate member first opening 234 isdisposed on the elongate member proximal end 226 and the elongate membersecond opening 236 is disposed between the elongate member proximal end226 and the elongate member distal end 228. The inflation lumen 238extends from the elongate member first opening 234 to the elongatemember second opening 236. The elongate member body 230 defines theelongate member curve 240 between the elongate member proximal end 226and the elongate member distal end 228. In the illustrated embodiment,the elongate member curve 240 is defined between the balloon 224 and theelongate member distal end 228.

In the illustrated embodiment, the elongate member 222 is adapted tomove between a first straight, or substantially straight, configurationand a second curved configuration. In the first straight, orsubstantially straight, configuration, the portion of the elongatemember 222 that defines the elongate member curve 240 is straight, orsubstantially straight, when it is disposed within the cannula lumen212, as illustrated in FIG. 2. For example, in embodiments in which theelongate member 222, a portion of the elongate member, or an elementdisposed within the elongate member 222 is biased to a curvedconfiguration, and the elongate member 222 is disposed within thecannula lumen 212, the elongate member 222 forms to the structuralarrangement of the cannula lumen 212 such that a portion of the elongatemember 222 (e.g., elongate member distal end 228) contacts the innerwall of the cannula 200 (e.g., the elongate member 222 forms a slightcurve within the cannula lumen 212). In the second curved configuration,the portion of the elongate member 222 that defines the elongate membercurve 240 is curved when it is free of, or disposed outside of, thecannula lumen 212, as illustrated in FIG. 3. Thus, the elongate member222 is biased to the second curved configuration. The portion of theelongate member 222 that forms a curve has a first radius of curvaturewhen it is disposed within the cannula lumen 212 and a second radius ofcurvature when it is free of the cannula lumen 212 that is less than thefirst radius of curvature.

The elongate member 222 has an elongate member first axis 242 and anelongate member second axis 244 disposed at an angle to the elongatemember first axis 242. The elongate member first axis 242 extendsthrough a portion, or the entirety, of the elongate member body 230 thatis disposed proximal to the elongate member curve 240. The elongatemember second axis 244 extends through the elongate member first axis242 and through the elongate member distal end 228 (e.g., center ofelongate member distal end 228) when the elongate member 222 is in thesecond curved configuration.

The elongate member 222 can define any suitable angle between theelongate member first axis 242 and the elongate member second axis 244,and skilled artisans will be able to select a suitable angle to definebetween an elongate member first axis and an elongate member second axisaccording to a particular embodiment based on various considerations,including the procedure intended to be performed. Example anglesconsidered suitable to define between an elongate member first axis andan elongate member second axis include, but are not limited to, acuteangles, obtuse angles, a 45 degree angle, a substantially 45 degreeangle, an angle about 45 degrees, a 90 degree angle, a substantially 90degree angle, an angle about 90 degrees, a 135 degree angle, asubstantially 135 degree angle, an angle about 135 degrees, and anyother angle considered suitable for a particular application. Forexample, the inventors have determined that when used within the sinus(e.g., sinus passage, airway, sinus cavity), a 90 degree angle,substantially 90 degree angle, or angle about 90 degrees, is consideredadvantageous.

The elongate member curve 240 can be formed in the elongate member 222using any suitable technique, and skilled artisans will be able toselect a suitable technique to form a curve in an elongate memberaccording to a particular embodiment based on various considerations,including the material that forms an elongate member. An exampletechnique considered suitable to form a curve in an elongate memberincludes, but is not limited to, positioning the elongate member in thesecond curved configuration and then applying heat to the portion of theelongate member in which it is desired to form a curve such that thecurve is incorporated into the material that forms the elongate member.

While the elongate member curve 240 has been illustrated as definedbetween the balloon 224 and the elongate member distal end 228, a curvecan be defined along any suitable portion, or the entirety, of anelongate member. Skilled artisans will be able to select a suitableportion of an elongate member to define a curve according to aparticular embodiment based on various considerations, including theprocedure intended to be performed. Example portions of an elongatemember considered suitable to define a curve, include, but are notlimited to, defining a curve from an elongate member proximal end to anelongate member distal end, between an elongate member proximal end andan elongate member distal end, between an elongate member proximal endand a balloon proximal end, between an elongate member proximal end anda balloon distal end, between a balloon proximal end and a balloondistal end, between a balloon distal end and an elongate member distalend, and any other portion of an elongate member considered suitable fora particular application.

While the elongate member curve 240 has been illustrated as formed inthe elongate member 222, a curve can alternatively be defined by thebody of a separate elongate member, or length of material, and attachedto the elongate member, elongate member distal end, embedded along theentire length, or a portion of the length, of the elongate member, ordisposed within a lumen defined by an elongate member. For example, aseparate elongate member having an elongate member proximal end,elongate member distal end, and elongate member body can define a curve,such as described above with respect to elongate member 222. Theseparate elongate member can then be attached to, or embedded within,the elongate member of a catheter using any suitable method ofattachment. Skilled artisans will be able to select a suitable method ofattachment between the elongate member of a catheter and a separateelongate member that defines a curve according to a particularembodiment based on various considerations, including the material thatforms the elongate member of the catheter. Example methods of attachmentconsidered suitable include, but are not limited to, heat fusing, usingadhesives, mechanical connections, welding, and any other method ofattachment considered suitable for a particular application. In theseembodiments, the material that forms the elongate member and theseparate elongate member that defines a curve can be the same, ordifferent from one another. Thus, the elongate member of a catheter cancomprise a first material and the separate elongate member can comprisea second material that is the same as the first material, or differentfrom the first material. Example materials considered suitable to formthe elongate member of a catheter and a separate elongate member thatdefines a curve include, but are not limited to, nitinol, thosedescribed herein (e.g., with respect to elongate member 222), and anyother material considered suitable for a particular embodiment.

The elongate member proximal end 226 can include any suitable connectorand/or adapter capable of attaching, or assisting with attaching, one ormore devices to the elongate member 222. Skilled artisans will be ableto select a suitable connector and/or adapter to include on an elongatemember according to a particular embodiment based on variousconsiderations, including the materials that form the elongate member.Example connectors and/or adapters considered suitable to include on anelongate member include, but are not limited to, threaded connectors,Tuohy Borst adapters, luer lock connectors, and any other connectorand/or adapter considered suitable for a particular application.

Optionally, the elongate member 222 can comprise a seeking devicedisposed on the elongate member distal end 228, near the elongate memberdistal end 228, or adjacent the elongate member distal end 228. Theseeking device can be formed of any suitable material and can compriseany suitable structure that can be used to locate an opening formed bythe wall of a bodily passage. The seeking device can be a separatecomponent attached to the elongate member distal end 228, or be formedas part of the elongate member 222. Example materials consideredsuitable to form a seeking device include, but are not limited to,biocompatible materials, materials that can be made biocompatible,metals such as stainless steel, titanium, polymers, Pebax (Pebax is aregistered trademark of Ato Chimie Corporation of Allee des Vosges,Courbevoie, France), nylon, polyethylene, polyurethane, silicone, andany other material considered suitable for a particular application.Thus, a seeking device can be formed of the same material as theelongate member, or a material that is different than the elongatemember. Examples of suitable structures considered suitable to form aseeking device include, but are not limited to, spheres, partialspheres, egg shaped structures, and any other structure consideredsuitable for a particular application. Alternatively, rounding off thematerial that forms an elongate member distal end can form a seekingdevice. Thus, an elongate member distal end can be round, or partiallyrounded.

While the elongate member 222 has been illustrated as having aparticular structural configuration defining an inflation lumen and anelongate member curve, an elongate member can have any suitablestructural configuration defining any suitable number of lumens and/orcurves. Skilled artisans will be able to select a suitable structuralconfiguration and number of lumens and/or curves to define on anelongate member according to a particular embodiment based on variousconsiderations, including the procedure intended to be performed.Example number of lumens and/or curves considered suitable to include onan elongate member include, but are not limited to, one, at least one,two, a plurality, three, four, and any other number considered suitablefor a particular application. For example, an elongate member body canoptionally define a device lumen or a guide wire lumen adapted toreceive a guide wire that extends from a first opening on elongatemember proximal end to a second opening on elongate member distal end.

The balloon 224 can be formed of any suitable material and can befabricated using any suitable method of manufacture, and skilledartisans will be able to select a suitable material to form a balloonand a suitable method of manufacture according to a particularembodiment based on various considerations, including the materials thatform an elongate member. Example materials considered suitable to form aballoon include, but are not limited to, biocompatible materials,materials that can be made biocompatible, flexible materials,substantially flexible materials, polymers, Pebax (Pebax is a registeredtrademark of Ato Chimie Corporation of Allee des Vosges, Courbevoie,France), nylon, polyethylene, polyurethane, and any other materialconsidered suitable for a particular application.

The balloon 224 can have any suitable structural arrangement, andskilled artisans will be able to select a suitable structuralarrangement for a balloon according to a particular embodiment based onvarious considerations, including the structural arrangement of thepassage wall being treated. For example, a balloon can have any suitablelength and inflated balloon diameter. The inventors have determined thatballoons that have a length between 1 centimeter and 3 centimeters, orbetween about 1 centimeter and about 3 centimeters, are consideredsuitable. In addition, the inventors have determined that balloons thathave a length of 2 centimeters, or about 2 centimeters, are consideredsuitable. The inventors have also determined that balloons that have aninflated balloon diameter in the second inflated configuration between 1millimeter and 9 millimeters, or between about 1 millimeter and about 9millimeters, are considered suitable. In addition, the inventors havedetermined that balloons that have an inflated balloon diameter in thesecond inflated configuration between 3 millimeters and 7 millimeters,or between about 3 millimeters and about 7 millimeters, are consideredsuitable.

In the illustrated embodiment, the balloon 224 is attached to theelongate member 222 between the elongate member proximal end 226 and theelongate member distal end 228 at a balloon proximal junction 250 and aballoon distal junction 252. The balloon 224 comprises a balloonproximal end 254, a balloon distal end 256, and a balloon wall 258. Theballoon wall 258 and the portion of the surface of the elongate member222 disposed within the balloon 224 define a balloon chamber 260 that isadapted to receive a fluid such that the balloon 224 can be movedbetween a first deflated configuration and a second inflatedconfiguration. In the deflated configuration the balloon 224 has a firstoutside diameter and in the inflated configuration the balloon 224 has asecond outside diameter that is greater than the first outside diameter.FIG. 2 illustrates the balloon 224 in the first deflated configurationand FIG. 3 illustrates the balloon 224 in the second inflatedconfiguration.

The balloon 224 is attached to the elongate member 222 such that theelongate member second opening 236 is in communication with the balloonchamber 260. With this structural arrangement, the balloon 224 isadapted to move between the first deflated configuration and secondinflated configuration as fluid is moved into and out of the balloonchamber 260 via the inflation lumen 238 and the elongate member secondopening 236.

The balloon proximal junction 250 and the balloon distal junction 252can comprise any suitable method of attachment between the elongatemember 222 and the balloon 224, and skilled artisans will be able toselect a suitable method of attachment between a balloon and an elongatemember according to a particular embodiment based on variousconsiderations, including the materials that form the elongate memberand balloon. Example methods of attachment considered suitable betweenan elongate member and a balloon include, but are not limited to,attachments formed by heat fusing, using adhesives, mechanicalconnections, and any other method considered suitable for a particularapplication.

A user inflates the balloon 224 by introducing a fluid, such as saline,into the inflation lumen 238 until the fluid passes through the elongatemember second opening 236 and into the balloon chamber 260. Theresulting pressure placed on the inner surface of the balloon wall 258by the fluid causes the balloon 224 to inflate and adopt the secondinflated configuration. To move the balloon 224 to the first deflatedconfiguration, vacuum pressure can be applied to the inflation lumen 238to remove fluid located within the balloon chamber 260 via the elongatemember second opening 236, resulting in the balloon 224 collapsing andadopting the first deflated configuration.

Additional structure can be attached to the balloon catheter 220 tofacilitate the inflation and deflation of the balloon 224, as describedabove. For example, an inflation device, such as a syringe, can beoperatively connected, or attached, to the balloon catheter 220 (e.g.,to elongate member proximal end 226) and adapted to move the balloon 224between the first deflated configuration and second inflatedconfiguration. For example, fluid can be introduced into a balloonchamber by applying a distally-directed force on a plunger associatedwith a conventional syringe. Alternatively, fluid can be removed fromballoon chamber by applying a proximally-directed force on a plungerassociated with a conventional syringe. Any inflation device capable offacilitating inflation and deflation of a balloon is consideredsuitable, and skilled artisans will be able to select a suitableinflation device according to a particular embodiment based on variousconsiderations, including the procedure intended to be performed.Example inflation devices considered suitable include, but are notlimited to, manually operated inflation devices, syringes,electromechanical inflation devices, pumps, and any other deviceconsidered suitable for a particular application.

Optionally, an elongate member can include one or more indicia disposedalong its length. The one or more indicia can be formed on the outersurface of the elongate member, or be embedded within the materialforming the elongate member. Alternatively, the one or more indicia cancomprise a raised protuberance that extends outward and away from theelongate member body. Each indicia can extend about the entirety, or aportion, of the circumference of an elongate member. For example, one ormore indicia can optionally be included on an elongate member toindicate the location of an elongate member curve. For example, a firstindicia can be disposed at a location on the elongate member such thatwhen the first indicia is located at, proximal to, or near, the cannulaproximal end while a portion of the elongate member is disposed withinthe cannula lumen, the elongate member curve is free, or disposedoutside of, the cannula lumen. A second indicia can be disposed distalto the first indicia at a location on the elongate member such that whenthe second indicia is located at, proximal to, or near, the cannulaproximal end while a portion of the elongate member is disposed withinthe cannula lumen, a portion, or the entirety, of the elongate membercurve disposed within the cannula lumen.

Alternative to, or in combination with, including one or more indicia toindicate the location of an elongate member curve, an elongate membercan optionally include one or more indicia that indicate the location ofa balloon. A first indicia can be disposed at a location on the elongatemember such that when the first indicia is located at, proximal to, ornear, the cannula proximal end while a portion of the elongate member isdisposed within the cannula lumen, the balloon is free, or disposedoutside of, the cannula lumen. A second indicia can be disposed distalto the first indicia at a location on the elongate member such that whenthe second indicia is located at, proximal to, or near, the cannulaproximal end while a portion of the elongate member is disposed withinthe cannula lumen, the balloon distal end is disposed at, near, orproximal to, the cannula distal end.

Alternative to, or in combination with, including one or more indicia toindicate the location of an elongate member curve, and/or a balloon, anelongate member can optionally include one or more indicia disposedalong its length that indicate the orientation of the elongate membercurve and/or elongate member distal end. For example, a first indiciacan be disposed along the elongate member length that correlates withthe direction in which the elongate member curve and/or elongate memberdistal end will extend when free of, or outside of, the cannula lumen.

Step 106 can be accomplished by applying a distally-directed force onany suitable portion of the cannula 200 such that the cannula 200 isadvanced toward a point of treatment. This step can be accomplished withthe assistance of direct visualization of the cannula (e.g., scope),transcutaneously, transillumination techniques (e.g., an optical fiberis disposed within a lumen defined by an elongate member, embeddedwithin the material that forms the elongate member, or is attached tothe outer surface of an elongate member and is attached to a lightsource), a camera, or any other suitable visualization technique.

An optional step comprises confirming placement of the cannula 200 at apoint of treatment. This step can be accomplished using directvisualization (e.g., scope), transcutaneously, transilluminationtechniques, a camera, or any other suitable visualization technique.Optionally, the cannula 200 can be positioned proximal to, distal to,at, or near, a point of treatment.

Step 108 can be accomplished by applying a distally-directed force onany suitable portion of the balloon catheter 220 such that it isadvanced distally through the cannula lumen 212 and the portion of theelongate member 222 that defines the elongate member curve 240 is freeof, or disposed outside of, the cannula lumen 212 and the elongatemember 222 moves from the first configuration to the second curvedconfiguration. Thus, the portion of the elongate member 222 that defineselongate member curve 240 is disposed distal to cannula distal end 204.This step is considered advantageous at least because the structuralarrangement of the elongate member 222 (e.g., curved relative to thecannula 200) provides a mechanism for locating an opening defined by apassage wall without requiring the guidance of a previously placed guidewire. Thus, any of the steps described herein can be accomplishedwithout a previously placed guide wire.

Alternatively, step 108 can comprise advancing the elongate member 222through the cannula lumen 212 such that a portion of the elongate member222 that defines the elongate member curve 240 is disposed distal tocannula distal end 204 and is free of, or outside of, the cannula lumen212. This moves the elongate member 222 from the first straight, orsubstantially straight configuration, to a configuration between thestraight, or substantially straight configuration, and the curvedconfiguration. The completion of this alternative step is consideredadvantageous in bodily passages that do not require an entire elongatemember curve to be advanced from a cannula lumen to complete a procedureor locate a point of treatment (e.g., opening defined by a passagewall).

An optional step comprises confirming that the portion the elongatemember 222 that defines the elongate member curve 240 is free of thecannula lumen 212. This step can be accomplished using directvisualization (e.g., scope), transcutaneously, transilluminationtechniques, a camera, locating one of one or more indicia on theelongate member, or any other suitable visualization technique.

Optionally, a portion, or the entirety, of a cannula and/or elongatemember (e.g., elongate member distal end, elongate member distal tip),or a distal tip of an elongate member, can be formed of, or include, aradiopaque material such that the location, orientation, and/or lengthof elongate member disposed distal to a cannula can be determined usingfluoroscopy, or x-ray. The radiopaque material can be added in anyfabrication method or absorbed into, or sprayed onto, the surface of theentirety, or a portion, of the cannula and/or elongate member. Anysuitable radiopaque material can be used including, but not limited to,barium sulfate, bismuth subcarbonate, zirconium dioxide, cadmium,tungsten, gold, tantalum, bismuth, platinum, iridium, and rhodium.

Step 110 can be accomplished by advancing the cannula 200 and/or theelongate member 222 toward the opening defined by the passage wall(e.g., applying a force on an axis that passes through the elongatemember lengthwise axis or first axis). This step can be accomplishedusing tactile feedback of the placement of the elongate member 222within the bodily passage (e.g., within the opening defined by thepassage wall) or visualizing the elongate member 222 using directvisualization (e.g., scope), transcutaneously, transilluminationtechniques, a camera, or any other suitable visualization technique. Forexample, once the elongate member distal end 228 has located the openingdefined by the passage wall, a portion of the elongate member 222 can bepassed through, or into, the opening such that a user will have tactilefeedback as to the positioning of the elongate member distal end 228within, or through, the opening.

An optional step comprises rotating the balloon catheter 220 (e.g.,elongate member 222) such that the elongate member distal end 228 ispositioned at, or directed toward, the opening defined by the passagewall. This step can be accomplished by applying torque to a portion ofthe cannula 202 and/or the elongate member 222 (e.g., about thelengthwise axis of the elongate member 222) when the elongate membercurve 240 is disposed distal to the cannula distal end 204.

Another optional step comprises determining if the elongate memberdistal end is disposed through the opening. This step can beaccomplished using direct visualization (e.g., scope), transcutaneously,transillumination techniques, a camera, tactile feedback, or using anyother suitable visualization technique.

Step 112 can be accomplished by applying a distally-directed force onany suitable portion of the elongate member 222 such that the balloon224 passes through the cannula lumen 212 and is disposed distal to thecannula distal end 204 and within the opening defined by the passagewall.

An optional step comprises confirming placement of the balloon 224within the opening defined by the passage wall. This step can beaccomplished using direct visualization (e.g., scope), transcutaneously,transillumination techniques, a camera, radiopaque material, or usingany other suitable visualization technique.

Another optional step comprises advancing the balloon 242 distal to, orpast, the opening defined by the passage wall. This step is consideredadvantageous at least because it provides a method of performingtreatment on the tissue of passage walls that define a bodily passages,such as a sinus cavity, that are distal to, or past, an opening definedby the passage wall (e.g., an ostium).

Alternative to completing the steps of navigating the elongate memberdistal end 228 toward the opening defined by the passage wall andadvancing the elongate member distal end 228 through the opening definedby the passage wall, a step comprising advancing the elongate memberdistal end 228 through a portion of the bodily passage can be completed.This alternative step is considered advantageous at least because itprovides a mechanism for advancing an elongate member 222 and a portion,or the entirety of, the elongate member curve 240 through the tortuousanatomy of a bodily passage such that the tissue of a passage walldefining the bodily passage can be treated. This step can beaccomplished by applying a distally-directed force on any suitableportion of an elongate member 222 such that elongate member curve 240,or a portion of elongate member curve 240, is disposed distal to cannuladistal end 204.

Step 114 can be accomplished by passing a fluid through the inflationlumen 238 and into the balloon chamber 260 to move the balloon 224 fromits first deflated configuration toward its second inflatedconfiguration, or to its second inflated configuration. For example, asyringe in communication with the inflation lumen 238 can be used tointroduce the fluid into the balloon chamber 260 by applying adistally-directed force on the plunger of the syringe. The amount of theexterior surface of the balloon 224 that contacts the tissue in thepassage wall, and the amount of pressure exerted by the exterior surfaceof the balloon 224 onto the tissue in the passage wall, will depend onthe amount of fluid introduced into the balloon chamber 260. An optionalstep comprises continuing the step of passing a fluid through theinflation lumen 238 and into the balloon chamber 260 until the balloon224 contacts and dilates the opening defined by the passage wall.

Example fluids considered suitable to pass through an inflation lumen238 and into a balloon chamber 260 include, but are not limited to,saline, water contrast, a mixture of one or more of saline, water,and/or contrast, and any other fluid considered suitable for aparticular application.

Step 116 can be accomplished by stopping the step of passing fluidthrough the inflation lumen 238 and into the balloon chamber 260. Thiscan be accomplished, for example, by stopping the application of thedistally-directed force on the plunger of the syringe.

Step 118 can be accomplished by removing the fluid, or a portion of thefluid, passed into the balloon chamber 260 to move the balloon 224toward the first deflated configuration. For example, a syringe incommunication with the inflation lumen 238 can be used to provide vacuumpressure to remove the fluid, or a portion of the fluid, from theballoon chamber 260 by applying a proximally-directed force on theplunger of the syringe. The amount of fluid removed from the balloonchamber 260 can vary depending on the procedure. For example alternativeto removing a portion of the fluid, all of the fluid, or substantiallyall of the fluid, can be removed from the balloon chamber 260.

Step 120 can be accomplished by applying a proximally-directed force onany suitable portion of the elongate member 222 such that the elongatemember 222 is withdrawn from the opening defined by the passage wall.

Step 122 can be accomplished by applying a proximally-directed force onany suitable portion of the elongate member 222 such that the elongatemember 222 is withdrawn from the cannula lumen 212. Optionally, thisstep can be omitted from method 100.

Step 124 can be accomplished by applying a proximally-directed force onany suitable portion of the cannula 200 such that the cannula 200 isremoved from the bodily passage.

While step 120, step 122, and step 124 have been described as separatesteps, step 120, step 122, and step 124 can be accomplished concurrentlywith one another, or combined in any other suitable manner. For example,step 120 and step 122 can be accomplished concurrently, or step 122 andstep 124 can be accomplished concurrently.

While an exemplary balloon catheter 220 has been illustrated asaccomplishing method 100, any suitable medical device can be used toaccomplish the methods described herein. Skilled artisans will be ableto select a suitable medical device to accomplish one or more stepsdescribed herein according to a particular embodiment based on variousconsiderations, including the procedure intended to be performed. Forexample, an irrigation catheter having an elongate member that defines acurve when it is free of, or outside of, a cannula lumen, as describedwith respect to elongate member 222, or any other medical device havingan elongate member that defines a curve when it is free of, or outsideof, a cannula lumen, as described with respect to elongate member 222,can be used to complete one or more steps and/or methods describedherein. Alternatively, a medical device having an elongate member thatdefines a curve, as described with respect to elongate member 222, canbe advanced free of a cannula into a bodily passage.

It is considered advantageous to complete method 100 in the orderillustrated and/or described. It is noted, however, that any order isconsidered suitable.

While various steps, alternative steps, and optional steps have beendescribed above with respect to treating tissue in a passage walldefining a bodily passage, these steps, alternative steps, and optionalsteps can be included in, accomplished concurrently with, and/oraccomplished in the alternative to, the methods, steps, alternativesteps, and/or optional steps described below with respect to treatingtissue in a passage wall defining a bodily passage and/or treatingtissue in a passage wall defining a sinus passage.

FIG. 4 is a flowchart representation of another exemplary method 270 oftreating tissue in a passage wall defining a bodily passage.

A step 272 comprises inserting a delivery device having a deliverydevice proximal end and a delivery device distal end into a bodilypassage such that the delivery device distal end is disposed within thebodily passage. The delivery device comprising a housing, cannula,pusher, and a catheter. The housing having a housing proximal end,housing distal end, and a housing body defining a housing lumen. Thecannula having a cannula proximal end attached to the housing, a cannuladistal end, and a cannula body defining a cannula lumen in communicationwith the housing lumen. The pusher slidably disposed within the housinglumen and having a pusher proximal end, pusher distal end, and a pusherbody defining a pusher lumen. The catheter comprising an elongate memberand balloon. The elongate member having an elongate member proximal endattached to the pusher, elongate member distal end disposed within thecannula lumen, elongate member length, and an elongate member body thatdefines an inflation lumen and an elongate member curve. The inflationlumen is in communication with the pusher lumen. The elongate memberlength extends from the elongate member proximal end to the elongatemember distal end. The elongate member curve is defined along a portionof the elongate member. The elongate member is adapted to move between afirst straight, or substantially straight, configuration in which theportion of the elongate member that defines elongate member curve isstraight, or substantially straight, when disposed within the cannulalumen and a second curved configuration in which the portion of elongatemember that defines the elongate member curve is curved when free of, oroutside of, the cannula lumen. The balloon is disposed on the elongatemember and has a balloon wall that defines a balloon chamber incommunication with the inflation lumen. The balloon is moveable betweena first deflated configuration and a second inflated configuration asfluid is moved into and out of the balloon chamber. Another step 274comprises navigating the delivery device distal end toward a point oftreatment within the bodily passage. The point of treatment comprises anopening defined by the wall of the bodily passage. Another step 276comprises applying a distally-directed force on the pusher such that thecatheter passes through the cannula lumen, the portion of the elongatemember that defines the elongate member curve is free of the cannulalumen, and the elongate member moves from the first straight, orsubstantially straight configuration, to the second curvedconfiguration. Another step 278 comprises locating the opening of thebodily passage. Another step 280 comprises continuing the application ofdistally-directed force on the pusher such that the catheter distal endpasses through the opening. Another step 282 comprises passing a fluidthrough the pusher lumen and inflation lumen and into the balloonchamber to move the balloon from the first deflated configuration towardthe second inflated configuration. Another step 284 comprises stoppingthe step of passing a fluid through the pusher lumen and inflation lumenand into the balloon chamber. Another step 286 comprises removing aportion of the fluid from the balloon chamber. Another step 288comprises withdrawing the catheter from the opening. Another step 290comprises withdrawing the delivery device from the bodily passage.

Step 272 can be accomplished by applying a distally-directed force onany suitable portion of a delivery device such that the delivery devicedistal end is disposed within the bodily passage (e.g., through anopening defined by a passage wall). Any suitable delivery device havingany suitable structural arrangement can be used to accomplish step 272,and skilled artisans will be able to select a suitable delivery deviceand structural arrangement for a delivery device according to aparticular embodiment based on various considerations, including thetissue desired to be treated. FIG. 5 illustrates an exemplary deliverydevice 300 for accomplishing one or more of the steps, and/or methods,described herein. The delivery device 300 has a delivery device proximalend 301, a delivery device distal end 303, and comprises a housing 302,a cannula 304, a pusher 306, and a catheter 420.

The housing 302 has a housing proximal end 310, a housing distal end312, and a housing body 314 that defines a first housing opening 316, asecond housing opening 318, and a housing lumen 320. The housing lumen320 extends from the first housing opening 316 to the second housingopening 318.

The housing 302 can be formed of any suitable material and have anysuitable structural arrangement, and skilled artisans will be able toselect a suitable material to form a housing and a suitable structuralarrangement for a housing according to a particular embodiment based onvarious considerations, including the desired bodily passage withinwhich a catheter is to be utilized. Example materials consideredsuitable to form a housing include, but are not limited to,biocompatible materials, materials that can be made biocompatible,polymers, such as nylon, polyethylene, and polycarbonate, a mixturethereof, or any other material considered suitable for a particularapplication.

The housing 302 can be fabricated using any suitable method ofmanufacture, and skilled artisans will be able to select a suitablemethod of manufacture to fabricate a housing according to a particularembodiment based on various considerations, including the material thatforms the housing. Example methods of manufacture considered suitable tofabricate a housing considered suitable include, but are not limited to,injection molding, and any other method of manufacture consideredsuitable for a particular application.

The cannula 304 has a cannula proximal end 322, a cannula distal end324, and a cannula body 326 that defines a first cannula opening 328, asecond cannula opening 330, and a cannula lumen 332. The cannula lumen332 extends from the first cannula opening 328 to the second cannulaopening 330. The cannula proximal end 322 is attached to the housingdistal end 312 such that the housing lumen 320 and the cannula lumen 332are in communication.

In the illustrated embodiment, the cannula 304 is rigid, orsubstantially rigid, relative to the catheter 420, or a portion of thecatheter 420, and can be formed of any suitable material, and skilledartisans will be able to select a suitable material to form a cannulaaccording to a particular embodiment based on various considerations,including the desired bodily passage within which a catheter is to bedeployed. Example materials considered suitable to form a cannulainclude, but are not limited to, biocompatible materials, materials thatcan be made biocompatible, metals such as stainless steel, titanium,nitinol, cobalt chromium, polymers, Pebax (Pebax is a registeredtrademark of Ato Chimie Corporation of Allee des Vosges, Courbevoie,France), nylon, polyethylene, polyurethane, silicone, coiled materials,braided materials, and any other material considered suitable for aparticular application. Alternatively, a cannula can be formed of thesame material as a catheter such that the cannula and catheter have thesame rigidity or flexibility.

The pusher 306 has a pusher proximal end 334, a pusher distal end 336disposed within the housing lumen 320, a pusher body 338, and a pusherlength that extends from the pusher proximal end 334 to the pusherdistal end 336. The pusher body 338 defines a first pusher opening 340,a second pusher opening 342, and a pusher lumen 344 that extends fromthe first pusher opening 340 to the second pusher opening 342. Thepusher distal end 336 is slidably disposed within the housing lumen 320(e.g., when the pusher 306 is in the first configuration). However,alternative embodiments can include a pusher 306 that has a distal end336 that is disposed in the cannula lumen 332, or between the housing302 and the cannula 304, when the pusher 306 is in the firstconfiguration).

The pusher 306 (e.g., pusher proximal end 334) can include any suitablestructural arrangement, connector, and/or adapter capable of attaching,or assisting with attaching, one or more devices (e.g., syringe,inflation device) to the pusher 306 such that the attached device is incommunication with the pusher lumen 344 and the balloon chamber 460 viathe first pusher opening 340, as described in more detail herein.Skilled artisans will be able to select a suitable structuralarrangement, connector, and/or adapter to include on a pusher accordingto a particular embodiment based on various considerations, includingthe materials that form the pusher. Example structural arrangements,connectors, and/or adapters considered suitable to include on a pusherinclude, but are not limited to, threads, threaded connectors, TuohyBorst adapters, luer lock connectors, and any other structuralarrangement, connector, and/or adapter considered suitable for aparticular application.

The pusher 306 can be formed of any suitable material and fabricatedusing any suitable method of manufacture, and skilled artisans will beable to select a suitable material to form a pusher and a suitablemethod of manufacture to fabricate a pusher according to a particularembodiment based on various considerations, such as the material thatforms the housing of a delivery device. Example materials consideredsuitable to form a pusher include, but are not limited to, biocompatiblematerials, materials that can be made biocompatible, metals, such asstainless steel, titanium, plastics, such as nylon, polyethylene,high-density polyethylene, and any other material considered suitablefor a particular application.

The catheter 420 is similar to the catheter 220 illustrated in FIGS. 2and 3 and described above, except as detailed below. Reference numbersin FIG. 4 refer to the same structural element or feature referenced bythe same number in FIGS. 2 and 3, offset by 200. Thus, catheter 420comprises an elongate member 422 and a balloon 424.

In the illustrated embodiment, the elongate member 422 is operativelyconnected, or attached to, the pusher 306 such that the inflation lumen438 is in communication with the pusher lumen 344. Attachment of theelongate member 422 to the pusher 306 can be accomplished using anysuitable method of attachment, and skilled artisans will be able toselect a suitable method of attachment according to a particularembodiment based on various considerations, such as the bodily passagewithin which a catheter is intended to be deployed. Example methods ofattachment considered suitable between an elongate member and pusherinclude, but are not limited to, insert molding, using an adhesive, heatfusing, welding, threaded connections, mechanical connections, and anyother method of attachment considered suitable for a particularapplication.

The pusher 306 has a pusher first configuration and a pusher secondconfiguration. In the first configuration, the pusher distal end 336 ispositioned such that at least a portion of, or the entirety of, theelongate member 422 is disposed within the cannula lumen 332. In theillustrated embodiment, when the pusher 306 is in the pusher firstconfiguration, the portion of the elongate member 422 that defines theelongate member curve 440 is disposed within the cannula lumen 332.Thus, when the pusher 306 is in the pusher first configuration, theelongate member 422 is in the straight, or substantially straight,configuration and the elongate member distal end 428 is disposed withinthe cannula lumen 332. In the pusher second configuration, the pusherdistal end 336 is advanced distally (e.g., by applying distally-directedforce on pusher proximal end 334) and positioned such that the portionof the elongate member 422 that defines the elongate member curve 440 isdisposed distal to the cannula distal end 324. Thus, when the pusher 306is in the pusher second configuration, the elongate member 422 is in thesecond curved configuration.

While an exemplary catheter 420 has been illustrated as beingoperatively connected, or attached, to the pusher 306, any suitablecatheter, or medical device, can be operatively connected, or attached,to a pusher, such that it is disposed within a cannula, as describedherein. Skilled artisans will be able to select a suitable medicaldevice to accomplish one or more steps described herein according to aparticular embodiment based on various considerations, including theprocedure intended to be performed. Example catheters and/or medicaldevices considered suitable to operatively connect, or attach, to apusher and position within a cannula lumen include, but are not limitedto, irrigation catheters having an elongate member that defines a curvewhen it is free of, or outside of, a cannula lumen (e.g., as describedwith respect to elongate member 422), elongate members that define acurve when it is free of, or outside of, a cannula lumen (e.g., asdescribed with respect to elongate member 422), balloon catheters havingan elongate member that defines a curve when it is free of, or outsideof, a cannula lumen (e.g., as described with respect to elongate member422), and any other medical device having an elongate member thatdefines a curve when it is free of, or outside of, a cannula lumen(e.g., as described with respect to elongate member 422) consideredsuitable for a particular application. For example, alternative to anelongate member defining an inflation lumen and having a balloondisposed along its length, an elongate member attached to a pusher andhaving an elongate member curve, as described herein, can define anirrigation lumen (e.g., that extends from an opening on the proximal endof the elongate member to an opening on the distal end of the elongatemember) and/or suction lumen (e.g., that extends from an opening on theproximal end of the elongate member to an opening at the distal end ofthe elongate member) for introducing and/or removing material from abodily passage, sinus passage, airway, sinus cavity, the urinary tract,or any other suitable bodily passage. Optionally, a pusher and/or anelongate member attached to the pusher can omit the inclusion of alumen.

While the catheter 420 has been illustrated as being disposed within thecannula lumen 332 and the elongate member 422 has been described asstraight, or substantially straight, when the pusher 306 is in thepusher first configuration, any suitable length of a catheter can bedisposed within a cannula lumen when a pusher is in the pusher firstconfiguration, and skilled artisans will be able to select a suitablelength of a catheter to position within a cannula lumen according to aparticular embodiment based on various considerations, such as thebodily passage within which the catheter is intended to be deployed.Example lengths of a catheter considered suitable to position within acannula lumen when a pusher is in a pusher first configuration include,but are not limited to, at least a portion of a catheter (e.g., elongatemember), the entire length of a catheter (e.g., elongate member), theportion of the catheter (e.g., elongate member) proximal to a curve, theportion of the catheter (e.g., elongate member) distal to a curve, suchthat a portion of the curve is disposed within the cannula lumen, suchthat a portion of the curve is disposed distal to the cannula, and anyother length considered suitable for a particular application.

Step 274 can be accomplished by applying a distally-directed force onany suitable portion of delivery device 300 (e.g., housing 302, pusher306) such that the delivery device distal end 301 is advanced toward apoint of treatment. This step can be accomplished with the assistance ofdirect visualization of the cannula (e.g., scope), transcutaneously,transillumination techniques, using a camera, or any other suitablevisualization technique.

While the point of treatment has been described as an opening defined bythe passage wall, the delivery devices, cannulas, and/or cathetersdescribed herein can be used to treat the tissue in a wall defining anysuitable bodily passage or opening. Skilled artisans will be able toselect a suitable tissue for treatment with a particular deliverydevice, catheter, and/or cannula based on various considerations,including the nature of the treatment intended to be performed. Examplesof other tissues considered suitable to treat using a delivery device,catheter, and/or cannula, such as those described herein, include, butare not limited to, the tissue of a passage wall defining a bodilypassage, an opening defined by a passage wall, tissue in a passage wallthat defines a sinus passage, tissue in a passage wall that defines anostium, tissue in a passage wall that defines a sinus cavity, tissue ina passage wall that defines an airway, tissue in a passage wall thatdefines the urinary tract, and any other tissue considered suitable fora particular application.

Step 276 can be accomplished by applying a distally-directed force onany suitable portion of pusher 306 and maintaining the position of thehousing 302, advancing housing 302 in a proximal direction (e.g., byapplying a proximally-directed force on any suitable portion of thehousing 302) while maintaining the position of pusher 306, or advancingpusher 306 in a distal direction relative to the housing 302. This stepis considered advantageous at least because the structural arrangementof the elongate member 422 (e.g., curved relative to the cannula 304)provides a mechanism for locating an opening defined by a passage wallwithout requiring the guidance of a previously placed guide wire. Thus,any of the steps described herein can be accomplished without apreviously placed guide wire.

Step 276 is accomplished such that the elongate member 422 is advancedthrough the cannula lumen 412 and the portion of the elongate member 422that defines the elongate member curve 440 is free of, or outside of,the cannula lumen 332 and the elongate member 422 moves from the firstconfiguration to the second curved configuration. Thus, the portion ofthe elongate member 422 that defines elongate member curve 440 isdisposed distal to the cannula distal end 324.

Alternatively, step 276 can comprise advancing the pusher 306 such thata portion of the elongate member 422 that defines the elongate membercurve 440 is disposed distal to cannula distal end 324 and free of, oroutside of, the cannula lumen 332 and the elongate member 422 moves fromthe first straight, or substantially straight configuration, to aconfiguration between the straight, or substantially straightconfiguration, and the curved configuration. The completion of thisalternative step is considered advantageous in bodily passages that donot require an entire elongate member curve to be advanced from acannula lumen to complete a procedure or locate a point of treatment(e.g., opening defined by a passage wall).

Step 278 can be accomplished by advancing the delivery device 300 towardthe opening defined by the passage wall (e.g., by applying a force alongan axis that passes through elongate member first axis 442 on anysuitable portion of the delivery device). Tactile feedback will beprovided to the user of the delivery device 300 once the opening definedby the passage wall has been located (e.g., the elongate member distalend 428 will enter, or pass through, the opening). These steps areconsidered advantageous at least because they can be accomplishedwithout a visualization device. Alternatively, step 278 can beaccomplished using direct visualization of the elongate member (e.g.,scope), transcutaneously, transillumination techniques, using a camera,or any other suitable visualization technique independent of, or incombination with, tactile feedback. An optional step comprises applyingtorque to any suitable portion the delivery device (e.g., pusher 306,housing 302, cannula 304) to cause the elongate member distal end 428 torotate relative to the cannula 304.

Step 280 can be accomplished by continuing the application of adistally-directed force on any suitable portion of the pusher 306 andmaintaining the position of the housing 302, advancing the housing 302in a proximal direction (e.g., by applying a proximally-directed forceon any suitable portion of the housing 302) while maintaining theposition of the pusher 306, or advancing the pusher 306 in a distaldirection (e.g., in combination with the housing 302), until theelongate member distal end 428 passes through the opening defined by thepassage wall. This step can be accomplished with the assistance ofdirect visualization of the elongate member 422 (e.g., scope),transcutaneously, transillumination techniques, using a camera, or anyother suitable visualization technique.

The length of the catheter 420 passed through the opening defined by thepassage wall will depend on the procedure intended to be completed. Forexample, the catheter 420 can be passed through the opening such thatthe balloon 424, or a portion of the balloon 424, is positioned within,distal to, beyond, or proximal to the opening. Alternatively, inprocedures in which the tissue in a wall defining a bodily passage isbeing treated, step 280 comprises continuing the application ofdistally-directed force on the pusher 306 such that the catheter 420 isadvanced through the second cannula opening 330 and the balloon 424 ispassed through the second cannula opening 330 and into the bodilypassage.

Step 282 can be accomplished by passing a fluid through the pusher lumen344 and the inflation lumen 438 and into the balloon chamber 460 to movethe balloon 424 from its first deflated configuration toward its secondinflated configuration. For example, a syringe in communication with thepusher lumen 344 and the inflation lumen 438 can be used to introducethe fluid into the balloon chamber 460. The amount of the exteriorsurface of the balloon 424 that contacts the tissue in the passage wall,and the amount of pressure exerted by the exterior surface of theballoon 424 onto the tissue in the passage wall, will depend on theamount of fluid introduced into the balloon chamber 460. Examples offluids considered suitable to pass through an inflation lumen and into aballoon chamber are described above.

Step 284 can be accomplished by stopping the step of passing fluidthrough the pusher lumen 344 and the inflation lumen 438 and into theballoon chamber 460. This can be accomplished, for example, by stoppingthe application of the distally-directed force on the plunger of thesyringe.

Step 286 can be accomplished by removing the fluid, or a portion of thefluid, passed into the balloon chamber 460. For example, a syringe influid communication with the pusher lumen 344 and the inflation lumen438 can be used to provide vacuum pressure to remove the fluid, or aportion of the fluid, from the balloon chamber 460. The amount of fluidremoved from the balloon chamber 460 can vary depending on theprocedure. For example alternative to removing a portion of the fluid,all of the fluid, or substantially all of the fluid, can be removed fromthe balloon chamber 460.

Step 288 can be accomplished by applying a proximally-directed force onany suitable portion of pusher 306 and maintaining the position of thehousing 302, advancing housing 302 in a distal direction (e.g., byapplying a distally-directed force on any suitable portion of thehousing 302) while maintaining the position of pusher 306 relative tothe housing 302, or advancing pusher 306 in a proximal directionrelative to the housing 302.

Step 290 can be accomplished by applying a proximally-directed force onany suitable portion of the delivery device 300 such that the deliverydevice 300 is withdrawn from the bodily passage.

While step 288 and step 290 have been described as separate steps, step288 and step 290 can be accomplished concurrently with one another.

It is considered advantageous to complete method 270 in the orderillustrated and/or described. It is noted, however, that any order isconsidered suitable.

While various steps, alternative steps, and optional steps have beendescribed above with respect to treating tissue in a passage walldefining a bodily passage, these steps, alternative steps, and optionalsteps can be included in, accomplished concurrently with, and/oraccomplished in the alternative to, the methods, steps, alternativesteps, and/or optional steps described above and/or below with respectto treating tissue in a passage wall defining a bodily passage and/orwith respect to treating tissue in a passage wall defining a sinuspassage.

FIG. 6 is a flowchart representation of an exemplary method 500 oftreating tissue in a passage wall defining a sinus passage.

A step 502 comprises inserting a delivery device having a deliverydevice proximal end and a delivery device distal end into a nasalpassage such that the delivery device distal end is disposed within thenasal passage. The delivery device comprising a housing, cannula,pusher, and a catheter. The housing having a housing proximal end,housing distal end, and a housing body defining a housing lumen. Thecannula having a cannula proximal end attached to the housing, a cannuladistal end, and a cannula body defining a cannula lumen in communicationwith the housing lumen. The pusher slidably disposed within the housinglumen and having a pusher proximal end, pusher distal end, and a pusherbody defining a pusher lumen. The catheter comprising an elongate memberand balloon. The elongate member having an elongate member proximal endattached to the pusher, elongate member distal end disposed within thecannula lumen, elongate member length, and an elongate member body thatdefines an inflation lumen and an elongate member curve. The inflationlumen in communication with the pusher lumen. The elongate member lengthextends from the elongate member proximal end to the elongate memberdistal end. The elongate member curve is defined along a portion of theelongate member. The elongate member is adapted to move between a firststraight, or substantially straight, configuration in which the portionof the elongate member that defines elongate member curve is straight,or substantially straight, when disposed within the cannula lumen and asecond curved configuration in which the portion of elongate member thatdefines the elongate member curve is curved when free of, or outside of,the cannula lumen. The balloon is disposed on the elongate member andhas a balloon wall that defines a balloon chamber in communication withthe inflation lumen. The balloon is moveable between a first deflatedconfiguration and a second inflated configuration as fluid is moved intoand out of the balloon chamber. Another step 504 comprises navigatingthe delivery device distal end toward a point of treatment. The point oftreatment comprising a maxillary sinus ostium defined by a sinus passagewall. Another step 506 comprises applying a distally-directed force onthe pusher such that the catheter passes through the cannula lumen andthe portion of the elongate member that defines the elongate membercurve is free of, or outside of, the cannula lumen and the elongatemember moves from the first straight, or substantially straightconfiguration, to the second curved configuration. Another step 508comprises locating the maxillary sinus ostium. Another step 510comprises continuing the application of distally-directed force on thepusher such that the catheter passes through the maxillary sinus ostium.Another step 512 comprises passing a fluid through the pusher lumen andinflation lumen and into the balloon chamber to move the balloon fromthe first deflated configuration toward the second inflatedconfiguration. Another step 514 comprises stopping the step of passingfluid through the pusher lumen and inflation lumen and into the balloonchamber. Another step 516 comprises removing a portion of the fluid fromthe balloon chamber. Another step 518 comprises withdrawing the catheterfrom the maxillary sinus ostium. Another step 520 comprises withdrawingthe delivery device from the nasal passage.

Step 502 can be accomplished by applying a distally-directed force onany suitable portion of a delivery device such that the delivery devicedistal end is disposed within the nasal passage. Any suitable deliverydevice having any suitable structural arrangement can be used toaccomplish step 502, and skilled artisans will be able to select asuitable delivery device and structural arrangement for a deliverydevice according to a particular embodiment based on variousconsiderations, including the bodily passage desired to be treated. Anexemplary delivery device 300 for accomplishing one or more of thesteps, and/or methods, described herein is illustrated in FIG. 5. Thedelivery device 300 has a delivery device proximal end 301, a deliverydevice distal end 303, and comprises a housing 302, a cannula 304, apusher 306, and a catheter 420.

Step 504 can be accomplished by applying a distally-directed force onany suitable portion of delivery device 300 such that the deliverydevice distal end 303 is advanced toward a point of treatment. This stepcan be accomplished with the assistance of direct visualization of thecannula (e.g., scope), transcutaneously, transillumination techniques,using a camera, or any other suitable visualization technique.

FIGS. 6A, 6B, 6C, and 6D illustrate the treatment of a bodily passageusing delivery device 300. FIG. 6A illustrates the delivery devicedistal end 303 passed through nostril 350 and disposed within a nasalpassage 352. The delivery device 300 has been advanced toward a point oftreatment. In the illustrated embodiment, the point of treatment is themaxillary sinus ostium 354 defined by the sinus passage wall 355. Themaxillary sinus ostium 354 provides access to the maxillary sinus cavity356. In FIGS. 6A and 6B, the maxillary sinus ostium 354 is blockedpreventing material within the maxillary sinus cavity 356 from drainingand air from circulating throughout the maxillary sinus cavity 356.

Step 506 can be accomplished by applying a distally-directed force onany suitable portion of pusher 306 and maintaining the position of thehousing 302, advancing the housing 302 in a proximal direction (e.g., byapplying a proximally-directed force on any suitable portion of thehousing 302) while maintaining the position of pusher 306, or advancingpusher 306 in a distal direction relative to the housing 302. FIG. 6Billustrates catheter 420 passed through cannula lumen 332 such that theportion of the elongate member 422 that defines the elongate membercurve 440 is free of, or outside of, the cannula lumen 332 and theelongate member 422 has moved from the first configuration to the secondcurved configuration. This step is considered advantageous at leastbecause the structural arrangement of the elongate member 422 (e.g.,curved relative to the cannula 304) provides a mechanism for locatingand treating the maxillary sinus ostium 354 without requiring theguidance of a previously placed guide wire. Thus, any of the stepsdescribed herein can be accomplished without a previously placed guidewire.

Step 508 can be accomplished by advancing the delivery device, or theelongate member distal end 428 toward the sinus passage wall 355 (e.g.,by applying a force along an axis that passes through elongate memberfirst axis 442 at an angle on any suitable portion of the deliverydevice). An optional step comprises applying torque to any suitableportion the delivery device 300 (e.g., housing 302, cannula 304, pusher306) to cause the elongate member distal end 428 to rotate relative tothe cannula 304 and/or bodily passage. Tactile feedback will be providedto the user of the delivery device 300 once the maxillary sinus ostium354 has been located (e.g., the elongate member distal end 428 willenter, or pass through, the maxillary sinus ostium 354). These steps areconsidered advantageous at least because they provide a mechanism forlocating the maxillary sinus ostium 354 without a visualization device.Alternatively, step 508 can be accomplished using direct visualizationof the elongate member (e.g., scope), transcutaneously,transillumination techniques, using a camera, or any other suitablevisualization technique independent of, or in combination with, tactilefeedback.

Step 510 can be accomplished by continuing the application ofdistally-directed force on any suitable portion of the pusher 306 andmaintaining the position of the housing 302, advancing housing 302 in aproximal direction (e.g., by applying a proximally-directed force on anysuitable portion of the housing 302) while maintaining the position ofpusher 306, or advancing pusher 306 in a distal direction relative tothe housing 302, until the catheter 420 passes through the maxillarysinus ostium 356. This step can be accomplished with the assistance ofdirect visualization of the cannula (e.g., scope), transcutaneously,transillumination techniques, using a camera, or any other suitablevisualization technique.

The length of the catheter 420 passed through the maxillary sinus ostium354 will depend on the procedure intended to be completed. In theillustrated embodiment, as shown in FIG. 6C, the elongate member distalend 428 is passed through the maxillary sinus ostium 354 such that theballoon 424 is positioned within the maxillary sinus ostium 354 and theelongate member distal end 428 is disposed within the maxillary sinuscavity 356. The positioning of the balloon 424 in this manner isconsidered advantageous at least because it provides a mechanism fordilating the maxillary sinus ostium 354 such that subsequent to dilationfluid can flow from the maxillary sinus cavity 356.

Alternatively, the elongate member distal end 428 can be passed into themaxillary sinus cavity 356 such that the balloon 424 is positionedwithin the maxillary sinus cavity 356. The balloon 424 can optionally bedisposed entirely, or partially, within the maxillary sinus cavity 356.The positioning of the balloon 424 in this manner is consideredadvantageous at least because it provides a mechanism for dilating themaxillary sinus cavity 356.

An optional step comprises confirming placement of the balloon 420 at adesired point of treatment. This step can be accomplished using anysuitable visualization device or technique. For example, this optionalstep can be accomplished with the assistance of direct visualization ofthe elongate member (e.g., scope), transcutaneously, usingtransillumination techniques (e.g., catheter includes a optical fiberattached to a light source), using a camera, or any other suitablevisualization technique.

Step 512 can be accomplished by passing a fluid through the pusher lumen344 and the inflation lumen 438 and into the balloon chamber 460 to movethe balloon 424 from its first deflated configuration toward its secondinflated configuration, or to the second configuration. For example, asyringe in communication with the pusher lumen 344 and the inflationlumen 438 can be used to introduce the fluid into the balloon chamber460. The amount of the exterior surface of the balloon 424 that contactsthe tissue in the maxillary sinus ostium 354, and the amount of pressureexerted by the exterior surface of the balloon 424 onto the tissue inthe maxillary sinus ostium 354, will depend on the amount of fluidintroduced into the balloon chamber 460. FIG. 6C illustrates catheter420 passed through the maxillary sinus ostium 354 and the balloon 424 inthe inflated configuration. Examples of fluids considered suitable topass through an inflation lumen 438 and into a balloon chamber 460 aredescribed above.

Step 514 can be accomplished by stopping the step of passing fluidthrough the pusher lumen 344 and inflation lumen 438 and into theballoon chamber 460. This can be accomplished, for example, by stoppingthe application of the distally-directed force on the plunger of thesyringe.

Step 516 can be accomplished by removing the fluid, or a portion of thefluid, passed into the balloon chamber 460. For example, a syringe incommunication with the pusher lumen 344 and the inflation lumen 438 canbe used to provide vacuum pressure to remove the fluid, or a portion ofthe fluid, from the balloon chamber 460. The amount of fluid removedfrom the balloon chamber 460 can vary depending on the procedure. Forexample alternative to removing a portion of the fluid, all of thefluid, or substantially all of the fluid, can be removed from theballoon chamber 460.

Optionally step 512, step 514, and 516 can be repeated.

Step 518 can be accomplished by applying a proximally-directed force onany suitable portion of pusher 306 and maintaining the position of thehousing 302, advancing housing 302 in a distal direction (e.g., byapplying a distally-directed force on any suitable portion of thehousing 302) while maintaining the position of pusher 306 relative tothe housing 302, or advancing pusher 306 in a proximal directionrelative to the housing 302.

Step 520 can be accomplished by applying a proximally-directed force onany suitable portion of the delivery device 300 (e.g., housing 302) suchthat the delivery device 300 is withdrawn from the nasal passage 352.FIG. 6D illustrates the maxillary sinus ostium 354 subsequent todilation and the removal of the catheter 420 from the maxillary sinusostium 354 and the delivery device 300 from the nasal passage 352. InFIG. 6D, the maxillary sinus ostium 354 is unblocked allowing materialwithin the maxillary sinus cavity 356 to drain and air to circulatethroughout the maxillary sinus cavity 356.

While step 518 and step 520 have been described as separate steps, step518 and step 520 can be accomplished concurrently with one another.

While method 500 has been described and illustrated as a method oftreating a maxillary sinus ostium 354 defined by a sinus passage wall355, the delivery devices, catheters, and/or cannulas described hereincan be used to treat any suitable opening and/or the tissue of anysuitable bodily passage, sinus passage, airway, and/or sinus cavity.Skilled artisans will be able to select a suitable opening and/or tissueto treat according to a particular embodiment based on variousconsiderations, including the treatment desired to be performed.

It is considered advantageous to complete method 500 in the orderillustrated and/or described. It is noted, however, that any order isconsidered suitable.

While various steps, alternative steps, and optional steps have beendescribed above with respect to treating a maxillary sinus ostiumdefined by a sinus passage wall, these steps, alternative steps, andoptional steps can be included in, accomplished concurrently with,and/or accomplished in the alternative to, the methods, steps,alternative steps, and/or optional steps described above and/or belowwith respect to treating tissue in a wall defining a bodily passage.

FIGS. 7, 8, and 9 illustrate another exemplary cannula 600, catheter620, and insert 700 for accomplishing any suitable method and/or step,such as those described herein. The cannula 600 is similar to thecannula 200 illustrated in FIGS. 2 and 3 and described above, except asdetailed below. The balloon catheter 620 is similar to the ballooncatheter 220 illustrated in FIGS. 2 and 3 and described above, except asdetailed below. Reference numbers in FIGS. 7, 8, and 9 refer to the samestructural element or feature referenced by the same number in FIGS. 2and 3, offset by 400.

In the illustrated embodiment, the elongate member body 630 defines aninflation port 631, a device port 633, an elongate member first opening634, an elongate member second opening 636, an elongate member thirdopening 635, an elongate member fourth opening 637, an inflation lumen638, a device lumen 639, and an elongate member curve 640.

The elongate member first opening 634 is disposed on the inflation port631 and the elongate member second opening 636 is disposed between theelongate member proximal end 626 and the elongate member distal end 628.The inflation lumen 638 extends from the elongate member first opening634 to the elongate member second opening 636. The elongate member thirdopening 635 is disposed on the elongate member proximal end 626 and theelongate member fourth opening 637 is disposed on the elongate memberdistal end 628. The device lumen 639 extends from the elongate memberthird opening 635 to the elongate member fourth opening 637. Theelongate member body 630 defines the elongate member curve 640 betweenthe elongate member proximal end 626 and the elongate member distal end628. In the illustrated embodiment, the elongate member curve 640 isdefined between the balloon 624 and the elongate member distal end 628.Optionally, the elongate member 622 can omit the inclusion of anelongate member curve 640 (e.g., predefined curve) and a curve can bedefined independently by an insert, such as insert 700, as describedbelow.

The inflation port 631 and/or device port 633 can include any suitableconnector and/or adapter capable of attaching, or assisting withattaching, one or more devices to the elongate member 622. Skilledartisans will be able to select a suitable connector and/or adapter toinclude on an elongate member according to a particular embodiment basedon various considerations, including the materials that form theelongate member. Example connectors and/or adapters considered suitableto include on an elongate member include, but are not limited to,threaded connectors, Tuohy Borst adapters, luer lock connectors, and anyother connector and/or adapter considered suitable for a particularapplication.

In the illustrated embodiment, the balloon 624 is attached to elongatemember 622 between the elongate member proximal end 626 and the elongatemember distal end 628 at the balloon proximal junction 650 and theballoon distal junction 652. The balloon 624 comprises a balloonproximal end 654, a balloon distal end 656, and a balloon wall 658. Theballoon wall 658 and the portion of the surface of the elongate member622 disposed within the balloon 624 define the balloon chamber 660 thatis adapted to receive a fluid such that the balloon 624 can be movedbetween a first deflated configuration and a second inflatedconfiguration. FIG. 7 illustrates the balloon 624 in the first deflatedconfiguration and FIG. 8 illustrates balloon 624 in the second inflatedconfiguration.

The balloon 624 is attached to the elongate member 622 such that theelongate member second opening 636 is in communication with the balloonchamber 660. With this structural arrangement, the balloon 624 isadapted to move between the first deflated configuration and secondinflated configuration as fluid is moved into and out of the balloonchamber 660 via the inflation lumen 638 and the elongate member secondopening 636.

In the illustrated embodiment, the insert 700 is disposed within thedevice lumen 639, as shown in FIGS. 7 and 8. For clarity, the insert 700is shown in FIG. 9 free of the device lumen 639. The insert 700comprises an insert proximal end 702, an insert distal end 704, and aninsert body 706. The insert 700 has an insert length that extends fromthe insert proximal end 702 to the insert distal end 704. The insertbody 706 defines a proximal portion 708, a distal portion 710, and aninsert curve 712.

The insert 700 has an insert length than is greater than the length ofthe catheter 720, a first outside diameter 709 along the proximalportion 708, and a second outside diameter 711 along the distal portion710. However, the length of a insert can alternatively be less than,equal to, or substantially equal to, the length of a catheter. The firstoutside diameter 709 is greater than the second outside diameter 711 andgreater than the inside diameter of the device lumen 639. The secondoutside diameter 711 is less than the inside diameter of device lumen639. The insert proximal portion 708 acts as a mechanical stop to distaladvancement of the insert proximal portion 708 beyond the elongatemember proximal end 626. Optionally, insert first portion can be omittedand an insert can have a continuous, or substantially continuous,outside diameter along its length.

The insert 700 is adapted to move between a first straight, orsubstantially straight, configuration and a second curved configuration.In the first straight, or substantially straight, configuration, theportion of the insert 700 that defines the insert curve 712 is straight,or substantially straight, when the elongate member 622 is disposedwithin the cannula lumen 612, as illustrated in FIG. 7. In the secondcurved configuration, the portion of the insert 700 that defines theinsert curve 712 is curved when the elongate member 622 is free of, ordisposed outside of, the cannula lumen 612, as illustrated in FIG. 8.Thus, the insert 700 is biased to the second curved configuration (e.g.,the insert 700 has a predefined curve).

The insert 700 has an insert first axis 714 and an insert second axis716 disposed at an angle to the insert first axis 714. The insert firstaxis 714 extends through a portion, or the entirety, of the insert body706 disposed proximal to the insert curve 712. The insert second axis716 extends through the insert first axis 714 and through the insertdistal end 704 (e.g., center of insert distal end 704) when the insert700 is free of the elongate member 622 and in the second curvedconfiguration.

In the illustrated embodiment, the insert second axis 716 is disposed ata first angle 717 relative to the insert first axis. The first angle 717is equal to, or substantially equal to, 45 degrees. Alternative anglesthat are considered suitable are illustrated in hidden lines in FIG. 9.For example, an insert curve 712 can be disposed such that an insertsecond axis 716′ is disposed at a second angle 717′ relative to aninsert first axis, or such that an insert second axis 716″ is disposedat a third angle 717″ relative to an insert first axis. The second angle717′ is equal to, or substantially equal to, 90 degrees. The third angle717″ is equal to, or substantially equal to, 135 degrees.

While particular angles have been described with respect to the insertcurve 712, an insert can define any suitable angle between an insertfirst axis and an insert second axis. Skilled artisans will be able toselect a suitable angle to define between an insert first axis and aninsert second axis according to a particular embodiment based on variousconsiderations, including the procedure intended to be performed.Example angles considered suitable to define between an insert firstaxis and an insert second axis include, but are not limited to, acuteangles, obtuse angles, a 45 degree angle, a substantially 45 degreeangle, an angle about 45 degrees, a 90 degree angle, a substantially 90degree angle, an angle about 90 degrees, a 135 degree angle, asubstantially 135 degree angle, an angle about 135 degrees, and anyother angle considered suitable for a particular application.

The insert curve 712 can be formed in the insert 700 using any suitabletechnique, and skilled artisans will be able to select a suitabletechnique to form a curve in an insert according to a particularembodiment based on various considerations, including the materialforming an insert. An example technique considered suitable to form acurve in an insert includes, but is not limited to, positioning theinsert in the second curved configuration and then applying heat to theportion of the insert in which it is desired to form a curve such thatthe curve is incorporated into the material that forms the insert.

The insert 700 can be formed of any suitable material and fabricatedusing any suitable technique, and skilled artisans will be able toselect a suitable material to form an insert and a suitable technique tofabricate an insert according to a particular embodiment based onvarious considerations, including the material that forms an elongatemember intended to be used with an insert. Example materials consideredsuitable to form an insert include, but are not limited to,biocompatible materials, materials that can be made biocompatible,metals such as stainless steel, titanium, nitinol, cobalt chromium,polymers, Pebax (Pebax is a registered trademark of Ato ChimieCorporation of Allee des Vosges, Courbevoie, France), nylon,polyethylene, polyurethane, silicone, coiled materials, braidedmaterials, and any other material considered suitable for a particularapplication. Optionally, an insert can be formed of a malleable materialsuch that the angle defined between an insert first axis and an insertsecond axis can be formed prior to the performed of a procedure and/oradjusted as needed.

In use, the insert 700 is advanced through the device lumen 639 suchthat the insert proximal portion 708 contacts the elongate memberproximal end 626 and the insert curve 712 is disposed within the devicelumen 639. The insert 700 is adapted to move the elongate member 622between the first straight configuration and the second curvedconfiguration, as shown in FIGS. 7 and 8, and as described herein.Alternatively, if the insert 700 omits the inclusion of the insertproximal end 708, the insert 700 can be advanced through the devicelumen 639 until the insert curve 712 is disposed entirety within, orpartially within, the device lumen 639.

Optionally, an optical fiber can be attached to the insert 700 ordisposed within, or attached within, the device lumen 639 such that atreatment site can be illuminated prior to, during, or subsequent totreatment being performed. Any suitable optical fiber can be used andoperatively connected to any suitable light source.

FIG. 10 illustrates an exemplary kit 780 comprising a cannula 800according to an embodiment, such as cannula 600 illustrated in FIG. 7; aballoon catheter 820 according to an embodiment, such as ballooncatheter 620 illustrated in FIGS. 7 and 8; a first insert 900 accordingto an embodiment, such as insert 700 illustrated in FIGS. 7, 8, and 9; asecond insert 920; a third insert 940; and instructions for use 960.

The first insert 900 defines a first angle between the insert first axisand the insert second axis. The second insert 920 defines a second anglebetween the insert first axis and the insert second axis. The thirdinsert 940 defines a third angle between the insert first axis and theinsert second axis. The first angle is different than the second angleand the second angle is different than the third angle. Alternatively, akit can include one or more inserts or two or more inserts, each havingdifferent angles defined between an insert first axis and an insertsecond axis, or at least two inserts having different angles definedbetween an insert first axis and an insert second axis.

While kit 780 has been described as including a first insert 900, asecond insert 920, and a third insert 940, a kit can include anysuitable number of inserts, each defining any suitable angle between aninsert first axis and an insert second axis. Skilled artisans will beable to select a suitable number of inserts to include in a kitaccording to a particular embodiment based on various considerations,including the type of procedure intended to be performed with thedevices included in a kit. Example number of inserts considered suitableto include in a kit include, but are not limited to, one, at least one,two, a plurality, three, four, and any other number considered suitablefor a particular application. Each of the inserts can have a differentangle defined between an insert first axis and an insert second axis, ortwo or more inserts can have the same angle defined between an insertfirst axis and an insert second axis. Optionally, a deflectable insert,such that insert 1100, can be included in any suitable kit, such as kit780, or any other kit described herein.

FIG. 11 is a flowchart representation of an exemplary method 1000 oftreating tissue in a passage wall defining a bodily passage.

A step 1002 comprises selecting an insert from one or more inserts. Theinsert has an insert proximal end, an insert distal end, an insertlength, and an insert body that defines an insert curve. The insertlength extends from the insert proximal end to the insert distal end.The insert curve is defined along a portion of the insert. The insert isadapted to move between a first straight, or substantially straight,configuration in which the portion of the insert that defines the insertcurve is straight, or substantially straight, when an elongate member isdisposed within the cannula lumen and a second curved configuration inwhich the portion of insert that defines the insert curve is curved whenthe elongate member is free of, or disposed outside of, the cannulalumen. Another step 1004 comprises passing the insert into a devicelumen defined by a catheter. The catheter disposed within a cannulahaving a cannula proximal end, a cannula distal end, and a cannula bodydefining a cannula lumen. The catheter having an elongate member andballoon. The elongate member having an elongate member proximal end, anelongate member distal end, an elongate member length, and an elongatemember body that defines an inflation lumen, a device lumen, and anelongate member curve. The elongate member length extends from theelongate member proximal end to the elongate member distal end. Theelongate member curve is defined along a portion of the elongate member.The elongate member is adapted to move between a first straight, orsubstantially straight, configuration in which the portion of theelongate member that defines the elongate member curve is straight, orsubstantially straight, when disposed within the cannula lumen and asecond curved configuration in which the portion of elongate member thatdefines the elongate member curve is curved when free of, or disposedoutside of, the cannula lumen. The balloon is disposed on the elongatemember and has a balloon wall that defines a balloon chamber incommunication with the inflation lumen. The balloon is moveable betweena first deflated configuration and a second inflated configuration asfluid is moved into and out of the balloon chamber. Another step 1006comprises inserting the cannula into a bodily passage such that thecannula distal end is disposed within the bodily passage. Another step1008 comprises navigating the cannula toward a point of treatment withinthe bodily passage. The point of treatment comprises an opening definedby the wall of the bodily passage. Another step 1010 comprises advancingthe elongate member distally through the cannula lumen such that theportion of the elongate member that defines the elongate member curve isfree of, or disposed outside of, the cannula lumen and the elongatemember moves from the first configuration to the second configuration.Thus, the elongate member adopts a curved configuration. Another step1012 comprises navigating the elongate member distal end toward theopening defined by the passage wall. Another step 1014 comprisesadvancing the elongate member distal end through the opening defined bythe passage wall such that the balloon is positioned through theopening. Another step 1016 comprises passing a fluid through theinflation lumen and into the balloon chamber to move the balloon towardthe second inflated configuration. Another step 1018 comprises stoppingthe step of passing a fluid through the inflation lumen and into theballoon chamber. Another step 1020 comprises removing a portion of thefluid from the balloon chamber. Another step 1022 comprises withdrawingthe elongate member from the opening defined by the passage wall.Another step 1024 comprises withdrawing the catheter from the cannulalumen. Another step 1026 comprises withdrawing the cannula from thebodily passage.

Step 1002 can be accomplished by selecting any suitable insert accordingto an embodiment, such as the embodiments described and illustratedherein. Skilled artisans will be able to second a suitable insertaccording to a particular embodiment based on various considerations,including the treatment intended to be performed. Examples of insertsconsidered suitable include, but are not limited to, insert 700, insert900, insert 920, insert 940, insert 1100, and any other insert describedherein and/or considered suitable for a particular application.

Step 1004 can be accomplished using any suitable cannula and/or catheteraccording to an embodiment, such as the embodiments described andillustrated herein. Skilled artisans will be able to select a suitablecannula and/or catheter according to a particular embodiment based onvarious considerations, including the treatment intended to beperformed. Examples of cannulas considered suitable include, but are notlimited to, cannula 200, cannula 600, and any other cannula describedherein and/or considered suitable for a particular application. Examplesof catheters considered suitable include, but are not limited to,catheter 220, catheter 620, and any other catheter described hereinand/or considered suitable for a particular application.

Step 1004 can be accomplished by introducing the insert distal end intothe proximal opening of a device lumen of a catheter and applying adistally-directed force on the insert until the proximal portion of theinsert contacts the proximal end of the elongate member, or until theinsert curve is entirety, or partially, disposed within the device lumenof the elongate member. Alternatively, in embodiments in which theinsert omits the inclusion of a proximal portion, the distally-directedforce can be applied to the insert until the insert curve is disposedwithin the device lumen of the elongate member.

Alternatively, an insert can be pre-loaded within an elongate membersuch that steps 1002 and 1004 can be omitted from method 1000. An insertcan be pre-loaded and/or inserted into any suitable catheter, such asthose described herein. For example, any of the catheters describedherein can include a lumen that extends from an opening on the proximalend of the catheter toward the distal end of the catheter (e.g., anopening on the distal end of the catheter) and any of the insertsdescribed herein can be advanced into, or positioned within, the lumendefined by the catheter.

Step 1006 can be accomplished as described above with respect to step102. Step 1008 can be accomplished as described above with respect tostep 106. Step 1010 can be accomplished as described above with respectto step 108. Step 1012 can be accomplished as described above withrespect to step 110. Step 1014 can be accomplished as described abovewith respect to step 112. Step 1016 can be accomplished as describedabove with respect to step 114. Step 1018 can be accomplished asdescribed above with respect to step 116. Step 1020 can be accomplishedas described above with respect to step 118. Step 1022 can beaccomplished as described above with respect to step 120. Step 1024 canbe accomplished as described above with respect to step 122. Step 1026can be accomplished as described above with respect to step 124. When aninsert is disposed within an elongate member, as described herein, anyof the steps described herein that include applying a force to acatheter and/or elongate member can optionally include simultaneously,or separately, applying a force in the same direction as the forceapplied to the catheter and/or elongate member on an insert.

It is considered advantageous to complete method 1000 in the orderillustrated and/or described. It is noted, however, that any order isconsidered suitable.

While various steps, alternative steps, and optional steps have beendescribed above with respect to treating tissue in a passage walldefining a bodily passage, these steps, alternative steps, and optionalsteps can be included in, accomplished concurrently with, and/oraccomplished in the alternative to, the methods, steps, alternativesteps, and/or optional steps described above and/or below with respectto treating tissue in a passage wall defining a bodily passage and/ortreating tissue in a passage wall defining a sinus passage.

FIGS. 12 and 13 illustrate another exemplary insert 1100 that can beused with any of the devices described herein and to complete anysuitable method and/or step, such as those described herein. Insert 1100is described as being used in combination cannula 600 and ballooncatheter 620. For example, the insert 1100 can be disposed within thedevice lumen 639, as shown in FIGS. 7 and 8, alternative to the insert700 illustrated in FIGS. 7 and 8, such that the distal end of the insert1100 is disposed proximal to the distal end 628 of the balloon catheter620. However, the insert 1100 can be used with any suitable device.

In the illustrated embodiment, the insert 1100 comprises a proximal end1102, a distal end 1104, a deflectable member 1106, a handle 1108, and atension member 1110. The deflectable member 1102 is configured to movebetween a first straight, or substantially straight, configuration, asshown in FIG. 12, and a second curved configuration, as shown in FIG.13. This provides a mechanism to move the device within which the insert1100 is disposed (e.g., catheter 620) between a first straight, orsubstantially straight, configuration and a second curved configurationduring use.

While a particular structural configuration has been illustrated for theinsert 1100, any suitable insert capable of moving between a straight,or substantially straight, configuration and a curved configuration canused with the devices described herein and/or to accomplish any of themethods and/or steps described herein. Skilled artisans will be able toselect a suitable insert to use in combination with the devicesdescribed herein and/or to accomplished any of the methods and/or stepsdescribed herein according to a particular embodiment based on variousconsiderations, such as the structural arrangement of a catheterintended to be used with the insert and/or the structural arrangement ata point of treatment. An example insert considered suitable to use incombination with the devices described herein and/or to complete one ormore of the methods and/or steps described herein includes the ReuterTip Deflecting Wire Guide Handle and Wire Guide provided by Cook Medicaland described in manual T-TDWIRE-REVO, published in February of 2012.The contents of this manual are hereby incorporated into this disclosurein its entirety. However, other inserts that include a deflectablemember can be used in combination with the devices described hereinand/or to complete one or more of the methods and/or steps describedherein.

The deflectable member 1106 a proximal end 1114, a distal end 1116, ashaft 1118, and a connector 1120. The shaft 1118 has a length 1117, anoutside diameter 1119, and a body 1122 that defines a lumen 1124. Thelength 1117 of the shaft 1118 is greater than the length of the catheter620. However, the shaft of a deflectable member can have any suitablelength, such as a length that is less than, equal to, or substantiallyequal to, the length of a device through which it is disposed. Theoutside diameter 1119 is less than the inside diameter of the devicelumen 639 of the catheter 620. The lumen 1124 extends from an opening onthe proximal end 1114 to an opening on the distal end 1116 of thedeflectable member 1106. However, alternative embodiments can include adeflectable member that defines a lumen that extends from an opening onthe proximal end to a location between the proximal end and the distalend such that the distal end is sealed, or capped.

The shaft 1118 of a deflectable member 1106 can be formed of anysuitable material and fabricated using any suitable technique, andskilled artisans will be able to select a suitable material to form ashaft of a deflectable member and a suitable technique to fabricate ashaft of a deflectable member according to a particular embodiment basedon various considerations, including the desired flexibility of theshaft. Example materials considered suitable to form a shaft include,but are not limited to, biocompatible materials, materials that can bemade biocompatible, metals such as stainless steel, titanium, nitinol,cobalt chromium, polymers, Pebax (Pebax is a registered trademark of AtoChimie Corporation of Allee des Vosges, Courbevoie, France), nylon,polyethylene, polyurethane, silicone, coiled materials, braidedmaterials, and any other material considered suitable for a particularapplication. For example, a first portion of a shaft can be formed as asolid tubular member and a second portion of a shaft can be formed of acoiled material to impart flexibility into the shaft.

The connector 1120 acts as a mechanical stop to distal advancement ofthe insert 1100 beyond the elongate member proximal end 626. Theconnector 1120 can comprise any suitable structure capable of attaching,or assisting with attaching, the handle 1108 to the deflectable member1106 and that defines a passageway through which the tension member 1110can be disposed. Skilled artisans will be able to select a suitableconnector to include on an insert according to a particular embodimentbased on various considerations, including the materials that form thedeflectable member included on an insert on which the connector is acomponent. Example structures considered suitable to include on aconnector include, but are not limited to, threaded connectors, TuohyBorst adapters, luer lock connectors, friction fit configurations, snapfit configurations, and any other structure considered suitable for aparticular application.

The handle 1108 comprises an elongate member 1130 and an actuator 1132slidably disposed on the elongate member 1130. The elongate member 1130has a proximal end 1134, a distal end 1136, and a body 1138 that definesa thumb ring 1140. The proximal end 1134 of the elongate member 1130includes a corresponding structure capable of attaching the handle 1108to the connector 1120, such as those described above with respect to theconnector 1120.

The actuator 1132 is disposed between the proximal end 1134 and thedistal end 1136 of the elongate member 1130 and comprises a body 1142that defines a first passageway 1144, a second passageway 1146, and athird passageway 1148. In addition, the actuator 1132 includes a lockscrew 1150 disposed within the third passageway 1148. The firstpassageway 1144 is sized and configured to receive a portion of theelongate member 1130. The second passageway 1146 is sized and configuredto receive a portion of the tension member 1110. The third passageway1148 is sized and configured to receive a portion of the lock screw 1150and is in communication with the second passageway 1146. The actuator1132 is slidably disposed on the elongate member 1130 such that theelongate member 1130 is positioned through the first passageway 1142.The lock screw 1150 provides a mechanism for releasably attaching aportion of the tension member 1110 to the actuator 1132, as described inmore detail herein. While a lock screw 1150 has been illustrated asproviding a mechanism to releasably attach the tension member 1110 tothe actuator 1132, any suitable technique or method of attachment can beused to releasably or fixedly attach a tension member to an actuator.

The actuator 1132 is movable between a first position and a secondposition. In the first position, the actuator 1132 is disposed a firstdistance from the distal end 1136 of the elongate member 1130 and in thesecond position the actuator 1132 is disposed a second distance from thedistal end 1136 of the elongate member 1130 that is greater than thefirst distance. The deflectable member 1106 is in the first straight, orsubstantially straight, configuration when the actuator 1132 is in thefirst position and the deflectable member 1106 is in the second curvedconfiguration when the actuator 1132 is in the second position.

While a an actuator 1132 that is slidably disposed on an elongate member1130 has been illustrated, an insert can include any suitable actuatorcapable of moving a deflectable member between a first straight, orsubstantially straight, configuration and a second curved configuration.Skilled artisans will be able to select a suitable actuator to includeon an insert according to a particular embodiment based on variousconsiderations, including the structural arrangement of the insert.Example actuators considered suitable to include on an insert includedepressible members, rotatable members, slidable members, linearactuators, pivotable actuators, levers, and any other actuatorconsidered suitable for a particular embodiment.

The tension member 1110 comprises a proximal end 1151, a distal end1152, and a body 1154. The proximal end 1151 of the tension member 1110is disposed within the second passageway 1146 defined by the actuator1132 and is releasably attached to the actuator 1132 using lock screw1150. The distal end 1152 of the tension member 1110 is attached withinthe lumen 1124 defined by the deflectable member 1106 (e.g., at thedistal end, proximal to the distal end). The tension member 1110 extendsfrom the proximal end 1151, through the connector 1120, and through thelumen 1124 defined by the deflectable member 1106, to the distal end1152.

The connector 1120, elongate member 1130, actuator 1132, and tensionmember 1110 can be formed of any suitable material and fabricated usingany suitable technique. Skilled artisans will be able to select asuitable material to form a connector, elongate member, actuator, and/ortension member of an insert and a suitable technique to fabricate aconnector, elongate member, actuator, and/or tension member of an insertaccording to a particular embodiment based on various considerations,including the material(s) that form a deflectable member. Examplematerials considered suitable to form a connector, elongate member,actuator, and/or tension member include, but are not limited to,biocompatible materials, materials that can be made biocompatible,metals such as stainless steel, titanium, nitinol, cobalt chromium,polymers, Pebax (Pebax is a registered trademark of Ato ChimieCorporation of Allee des Vosges, Courbevoie, France), nylon,polyethylene, polyurethane, silicone, coiled materials, braidedmaterials, and any other material considered suitable for a particularapplication.

The insert 1100 is adapted to move between a first straight, orsubstantially straight, configuration and a second curved configuration.In the first straight, or substantially straight, configuration, theactuator 1132 is in the first position and deflectable member 1106 isstraight, or substantially straight. In the second curved configuration,the actuator 1132 is in the second position and the and deflectablemember 1106 defines an insert curve 1160 between the proximal end 1114and the distal end 1116 of the deflectable member 1106. Therefore, whenthe insert 1100 is disposed within the lumen of another device theportion of the insert 1100 that defines the insert curve 1160 is curvedand forms a curve in the device through which the insert is disposed.For example, when the insert 1100 is disposed within the device lumen639 of catheter 620, the portion of the insert 1100 that defines theinsert curve 1160 is curved and forms a curve in the catheter 620 alongits length. The catheter 620 is straight, or substantially straight,when the insert 1100 is in the first configuration (e.g., actuator 1132is in the first position) and the catheter 620 is curved when the insert1100 is in the second configuration (e.g., actuator 1132 is in thesecond position). The catheter 620, therefore, is adapted to adopt theconfiguration of the insert 1100 (e.g., deflectable member 1106).

An insert can define any suitable angle between a first axis disposedalong a first portion of the insert that is disposed proximal to theinsert curve and a second axis disposed along a second portion of theinsert disposed distal to the insert curve. Skilled artisans will beable to select a suitable angle to define between a first axis and asecond axis according to a particular embodiment based on variousconsiderations, including the procedure intended to be performed.Example angles considered suitable to define between a first axis and asecond axis include, but are not limited to, acute angles, obtuseangles, a 45 degree angle, a substantially 45 degree angle, an angleabout 45 degrees, a 90 degree angle, a substantially 90 degree angle, anangle about 90 degrees, a 135 degree angle, a substantially 135 degreeangle, an angle about 135 degrees, and any other angle consideredsuitable for a particular application.

In use, the insert 1100 is advanced through the device lumen 639 suchthat the distal end 1116 of the deflectable member 1106 is disposedproximal to the distal end 628 of the catheter 620 and/or such that theconnector 1120 contacts the elongate member proximal end 626. The insert1100 is adapted to move the elongate member 622 between the firststraight configuration and the second curved configuration.

Optionally, an optical fiber can be attached to the insert 1100 ordisposed within, or attached within, the device lumen 639 such that atreatment site can be illuminated prior to, during, or subsequent totreatment being performed. Any suitable optical fiber can be used andoperatively connected to any suitable light source.

FIG. 14 is a flowchart representation of an exemplary method 1200 oftreating tissue in a passage wall defining a bodily passage.

A step 1202 comprises selecting an insert. The insert has an insertproximal end, an insert distal end, and is adapted to define an insertcurve. The insert is adapted to move between a first straight, orsubstantially straight, configuration and a second curved configurationin which the insert defines the insert curve. Another step 1204comprises passing the insert into a device lumen defined by a catheter.The catheter disposed within a cannula having a cannula proximal end, acannula distal end, and a cannula body defining a cannula lumen. Thecatheter having an elongate member and balloon. The elongate memberhaving an elongate member proximal end, an elongate member distal end,an elongate member length, and an elongate member body that defines aninflation lumen, and a device lumen. The elongate member length extendsfrom the elongate member proximal end to the elongate member distal end.The elongate member is adapted to define an elongate member curve whenthe insert is in the second configuration (e.g., actuator 1132 is in thesecond position). The elongate member is adapted to move between a firststraight, or substantially straight, configuration and a second curvedconfiguration in which the elongate member defines the elongate membercurve. The elongate member is in the first configuration when the insertis in the first configuration (e.g., actuator 1132 is in the firstposition) and the elongate member is in the second configuration whenthe insert is in the second configuration (e.g., actuator 1132 is in thesecond position). The balloon is disposed on the elongate member and hasa balloon wall that defines a balloon chamber in communication with theinflation lumen. The balloon is moveable between a first deflatedconfiguration and a second inflated configuration as fluid is moved intoand out of the balloon chamber. Another step 1206 comprises insertingthe cannula into a bodily passage such that the cannula distal end isdisposed within the bodily passage. Another step 1208 comprisesnavigating the cannula toward a point of treatment within the bodilypassage. The point of treatment comprises an opening defined by the wallof the bodily passage. Another step 1210 comprises advancing theelongate member distally through the cannula lumen such that the portionof the insert that defines the insert curve is free of, or disposedoutside of, the cannula lumen. Another step 1212 comprises moving theactuator of the insert from the first position to the second positionsuch that the insert moves to the second curved configuration and theelongate member moves to the second curved configuration. Another step1214 comprises navigating the elongate member distal end toward theopening defined by the passage wall. Another step 1216 comprisesadvancing the elongate member distal end through the opening defined bythe passage wall such that the balloon is positioned through theopening. Another step 1218 comprises passing a fluid through theinflation lumen and into the balloon chamber to move the balloon towardthe second inflated configuration. Another step 1220 comprises stoppingthe step of passing a fluid through the inflation lumen and into theballoon chamber. Another step 1222 comprises removing a portion of thefluid from the balloon chamber. Another step 1224 comprises withdrawingthe elongate member from the opening defined by the passage wall.Another step 1226 comprises moving the actuator of the insert from thesecond position to the first position such that the insert moves to thefirst configuration and the elongate member moves to the first curvedconfiguration. Another step 1228 comprises withdrawing the catheter fromthe cannula lumen. Another step 1230 comprises withdrawing the cannulafrom the bodily passage.

Step 1202 can be accomplished by selecting any suitable insert accordingto an embodiment, such as the embodiments described and illustratedherein. Skilled artisans will be able to second a suitable insertaccording to a particular embodiment based on various considerations,including the treatment intended to be performed. Examples of insertsconsidered suitable include, but are not limited to, insert 1100, andany other insert capable of moving between a first straight, orsubstantially straight, configuration and a second curved configuration.

Step 1204 can be accomplished using any suitable cannula and/or catheteraccording to an embodiment, such as the embodiments described andillustrated herein. Skilled artisans will be able to select a suitablecannula and/or catheter according to a particular embodiment based onvarious considerations, including the treatment intended to beperformed. Examples of cannulas considered suitable include, but are notlimited to, cannula 200, cannula 600, and any other cannula describedherein and/or considered suitable for a particular application. Examplesof catheters considered suitable include, but are not limited to,catheter 220, catheter 620, and any other catheter described hereinand/or considered suitable for a particular application.

Step 1204 can be accomplished by introducing the insert distal end intothe proximal opening of a device lumen of a catheter and applying adistally-directed force on the insert until the distal end of thedeflectable member of the insert is disposed proximal to the distal endof the catheter, the connector of the insert contacts the proximal endof the elongate member, and/or until the portion of the deflectablemember that defines the insert curve is entirety, or partially, disposedwithin the device lumen of the elongate member.

Alternatively, an insert can be pre-loaded within an elongate membersuch that steps 1202 and 1204 can be omitted from method 1200. An insertcan be pre-loaded and/or inserted into any suitable catheter, such asthose described herein. For example, any of the catheters describedherein can include a lumen that extends from an opening on the proximalend of the catheter toward the distal end of the catheter (e.g., anopening on the distal end of the catheter) and any of the insertsdescribed herein can be advanced into, or positioned within, the lumendefined by the catheter.

Step 1206 can be accomplished as described above with respect to step102. Step 1208 can be accomplished as described above with respect tostep 106. Step 1210 can be accomplished as described above with respectto step 108.

Step 1212 can be accomplished by applying a proximally-directed force(e.g., toward the proximal end of the elongate member) on the actuatorwhile maintaining the position of the elongate member of the insert suchthat the actuator moves from the first position to the second position,the deflectable member moves from the first straight, or substantiallystraight, configuration to the second curved configuration, and theelongate member moves from the first straight, or substantiallystraight, configuration to the second curved configuration.Alternatively, the position of the actuator can be maintained while adistally-directed force (e.g., toward the distal end of the deflectablemember) is applied on the elongate member, or a proximally-directedforce can be applied on the actuator while a distally-directed force isapplied on the elongate member, to move the actuator to the secondposition.

Step 1214 can be accomplished as described above with respect to step110. Step 1216 can be accomplished as described above with respect tostep 112. Step 1218 can be accomplished as described above with respectto step 114. Step 1220 can be accomplished as described above withrespect to step 116. Step 1222 can be accomplished as described abovewith respect to step 118. Step 1224 can be accomplished as describedabove with respect to step 120.

Step 1226 can be accomplished by applying a distally-directed force(e.g., toward the distal end of the elongate member) on the actuatorwhile maintaining the position of the elongate member of the insert suchthat the actuator moves from the second position to the first position,the deflectable member moves from the second curved configuration to thefirst straight, or substantially straight, configuration, and theelongate member moves from the second curved configuration to the firststraight, or substantially straight, configuration. Alternatively, theposition of the actuator can be maintained while a proximally-directedforce (e.g., toward the proximal end of the elongate member) is appliedon the elongate member, or a distally-directed force can be applied onthe actuator while a proximally-directed force is applied on theelongate member, to move the actuator to the first position.

Step 1228 can be accomplished as described above with respect to step122. Step 1230 can be accomplished as described above with respect tostep 124. When an insert is disposed within an elongate member, asdescribed herein, any of the steps described herein that includeapplying a force to a catheter and/or elongate member can optionallyinclude simultaneously, or separately, applying a force in the samedirection as the force applied to the catheter and/or elongate member onan insert.

It is considered advantageous to complete method 1200 in the orderillustrated and/or described. It is noted, however, that any order isconsidered suitable.

While various steps, alternative steps, and optional steps have beendescribed above with respect to treating tissue in a passage walldefining a bodily passage, these steps, alternative steps, and optionalsteps can be included in, accomplished concurrently with, and/oraccomplished in the alternative to, the methods, steps, alternativesteps, and/or optional steps described above with respect to treatingtissue in a passage wall defining a bodily passage and/or treatingtissue in a passage wall defining a sinus passage.

The foregoing detailed description provides exemplary embodiments of theinvention and includes the best mode for practicing the invention. Thedescription and illustration of embodiments is intended only to provideexamples of the invention, and not to limit the scope of the invention,or its protection, in any manner.

What is claimed is:
 1. A delivery device, comprising: a housing having ahousing proximal end, a housing distal end, and a housing body defininga housing lumen; a cannula having a cannula proximal end, a cannuladistal end, and a cannula body defining a cannula lumen, the cannulaattached to the housing such that the housing lumen and the cannulalumen are in communication; a pusher having a pusher proximal end, apusher distal end slidably disposed within the housing lumen, and apusher body that defines a pusher lumen, the pusher moveable between apusher first configuration and a pusher second configuration; and acatheter attached to the pusher and having at least a portion disposedwithin the cannula lumen, the catheter comprising an elongate member anda balloon, the elongate member having an elongate member proximal end,an elongate member distal end, and an elongate member body defining aninflation lumen in communication with the pusher lumen and an elongatemember curve, the balloon disposed on the elongate member and having awall defining a balloon chamber in communication with the inflationlumen, the balloon moveable between a first deflated configuration and asecond inflated configuration as fluid is moved into and out of theballoon chamber, the elongate member adapted to move between a firstsubstantially straight configuration in which the portion of theelongate member that defines the elongate member curve is substantiallystraight when disposed within the cannula lumen and a second curvedconfiguration when the portion of the elongate member that defines theelongate member curve is free of the cannula lumen.
 2. The deliverydevice of claim 1, wherein the elongate member has an elongate memberfirst axis and an elongate member second axis, the elongate member firstaxis extending along a portion of the elongate member body disposedproximal to the elongate member curve, the elongate member second axisextending through the elongate member first axis and the elongate memberdistal end; and wherein the elongate member second axis is disposed atan angle to the elongate member first axis.
 3. The delivery device ofclaim 2, wherein the elongate member second axis is disposed at an angleselected from the group consisting of a substantially 45 degree angle, asubstantially 90 degree angle, and a substantially 135 degree angle tothe elongate member first axis.
 4. The delivery device of claim 2,wherein the elongate member second axis is disposed at a substantially90 degree angle to the elongate member first axis.
 5. The deliverydevice of claim 2, wherein the elongate member curve is defined betweenthe elongate member proximal end and the elongate member distal end. 6.The delivery device of claim 2, wherein the elongate member curve isdefined from a location between the elongate member proximal end and theelongate member distal end to the elongate member distal end.
 7. Thedelivery device of claim 6, wherein the elongate member second axis isdisposed at an angle selected from the group consisting of asubstantially 45 degree angle, a substantially 90 degree angle, and asubstantially 135 degree angle to the elongate member first axis.
 8. Thedelivery device of claim 6, wherein the elongate member second axis isdisposed at a substantially 90 degree angle to the elongate member firstaxis.
 9. The delivery device of claim 2, wherein the elongate membercurve is defined between the balloon and the elongate member distal end.10. The delivery device of claim 9, wherein the elongate member secondaxis is disposed at an angle selected from the group consisting of asubstantially 45 degree angle, a substantially 90 degree angle, and asubstantially 135 degree angle to the elongate member first axis. 11.The delivery device of claim 9, wherein the elongate member second axisis disposed at a substantially 90 degree angle to the elongate memberfirst axis.
 12. The delivery device of claim 2, wherein the balloon hasa balloon proximal end and a balloon distal end; and wherein theelongate member curve is defined between the balloon distal end and theelongate member distal end.
 13. The delivery device of claim 12, whereinthe elongate member second axis is disposed at an angle selected fromthe group consisting of a substantially 45 degree angle, a substantially90 degree angle, and a substantially 135 degree angle to the elongatemember first axis.
 14. The delivery device of claim 10, wherein theelongate member second axis is disposed at a substantially 90 degreeangle to the elongate member first axis.
 15. The delivery device ofclaim 2, wherein a portion of the elongate member contacts the cannulabody when the elongate member is in the first substantially straightconfiguration.
 16. A delivery device, comprising: a housing having ahousing proximal end, a housing distal end, and a housing body defininga housing lumen; a cannula having a cannula proximal end, a cannuladistal end, and a cannula body defining a cannula lumen, the cannulaattached to the housing such that the housing lumen and the cannulalumen are in communication; a pusher having a pusher proximal end, apusher distal end slidably disposed within the housing lumen, and apusher body that defines a pusher lumen, the pusher moveable between apusher first configuration and a pusher second configuration; and acatheter attached to the pusher and having at least a portion disposedwithin the cannula lumen, the catheter comprising an elongate member anda balloon, the elongate member having an elongate member proximal end,an elongate member distal end, and an elongate member body defining aninflation lumen in communication with the pusher lumen and an elongatemember curve, the balloon disposed on the elongate member and having awall defining a balloon chamber in communication with the inflationlumen, the balloon moveable between a first deflated configuration and asecond inflated configuration as fluid is moved into and out of theballoon chamber, the elongate member adapted to move between a firstsubstantially straight configuration in which the portion of theelongate member that defines the elongate member curve is substantiallystraight and a second curved configuration; wherein the elongate membercurve is defined between the balloon and the elongate member distal end;and wherein the elongate member is biased to the second curvedconfiguration.
 17. The delivery device of claim 16, wherein the elongatemember curve is defined between the balloon distal end and the elongatemember distal end.
 18. The delivery device of claim 16, wherein theelongate member has an elongate member first axis and an elongate membersecond axis, the elongate member first axis extending along a portion ofthe elongate member body disposed proximal to the elongate member curve,the elongate member second axis extending through the elongate memberfirst axis and the elongate member distal end; and wherein the elongatemember second axis is disposed at an angle to the elongate member firstaxis.
 19. The delivery device of claim 16, wherein the elongate membersecond axis is disposed at a substantially 90 degree angle to theelongate member first axis.
 20. A delivery device, comprising: a housinghaving a housing proximal end, a housing distal end, and a housing bodydefining a housing lumen; a cannula having a cannula proximal end, acannula distal end, and a cannula body defining a cannula lumen, thecannula attached to the housing such that the housing lumen and thecannula lumen are in communication; a pusher having a pusher proximalend, a pusher distal end slidably disposed within the housing lumen, anda pusher body that defines a pusher lumen, the pusher moveable between apusher first configuration and a pusher second configuration; and acatheter attached to the pusher and having at least a portion disposedwithin the cannula lumen, the catheter comprising an elongate member anda balloon, the elongate member having an elongate member proximal end,an elongate member distal end, and an elongate member body defining aninflation lumen in communication with the pusher lumen and an elongatemember curve, the balloon disposed on the elongate member and having awall defining a balloon chamber in communication with the inflationlumen, the balloon moveable between a first deflated configuration and asecond inflated configuration as fluid is moved into and out of theballoon chamber, the elongate member adapted to move between a firstsubstantially straight configuration in which the portion of theelongate member that defines the elongate member curve is substantiallystraight and a second curved configuration; wherein the elongate membercurve is defined between the balloon distal end and the elongate memberdistal end; wherein the elongate member is biased to the second curvedconfiguration; wherein the elongate member has an elongate member firstaxis and an elongate member second axis, the elongate member first axisextending along a portion of the elongate member body disposed proximalto the elongate member curve, the elongate member second axis extendingthrough the elongate member first axis and the elongate member distalend; and wherein the elongate member second axis is disposed at asubstantially 90 degree angle to the elongate member first axis.